Talent.com
Sr Quality Specialist

Sr Quality Specialist

bioMerieux Inc.Salt Lake City, UT, United States
30+ days ago
Job type
  • Full-time
Job description

Description

Position Summary

The Quality Assurance (QA) department provides Quality support across various company departments. The department is organized into distinct subunits, consisting of Metrology, Document Control, Reagent Quality, Instrument Quality, Servicing Quality, and Incoming Material QC. Depending on the sub-unit, Quality Specialists may work on quality improvement projects, monitor NCR's (including associated activities), revise existing procedures, train and mentor QA personnel, manage CAL / PM systems, process change control and implementation orders, and perform specialized inspections for raw materials. This position builds upon the skills and responsibilities of a Quality Specialist and requires an increased level of self-direction and motivation. This position requires a high level of self-direction and motivation. Timely and accurate work is expected. This position regularly interacts and collaborates with other departments. The work is fast paced, requires prioritization of daily tasks, and attention to detail. Effective communication, written and verbal, is critical.

Primary Duties

  • Perform all work in compliance with company policy and within the guidelines of its Quality System.
  • Responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.
  • May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.
  • Work on quality improvement projects, (e.g. projects stemming from CAPAs, training deficiencies, and general procedural improvements)
  • May present project related information to management as requested.
  • Work cross-functionally to design new processes as needed
  • Other Duties - see relevant Appendix section.

Sumpplemental Data

  • Minimal domestic travel may be required for training purposes
  • Training and Education

  • High school diploma or equivalent is required
  • Associate degree (or higher) in a life science or engineering discipline is preferred.
  • Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and / or 21 CFR 820 is required
  • Completion of the Salt Lake Community College Medical Device Manufacturing Program or equivalent (e.g. ASQ certification; Six Sigma certification; life science or engineering related college degree).
  • Experience

  • Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.
  • Minimum additional 2-year experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system.
  • Knowledge, Sills and Abilities

  • Effective written and verbal communication skills.
  • Proficiency in MS Office tools, including Outlook, Word, and Excel.
  • General computer operation.
  • Attention to detail is fundamental to this position.
  • Ability to accurately follow written and verbal instructions.
  • Organization skills as needed to maintain paperwork and task schedule.
  • Proficiency in internet navigation.
  • Basic math proficiency.
  • Ability to develop and write standardized and clear instructions.
  • Working Conditions and other physical requirements

  • Ability to remain in stationary position, often standing, for prolonged periods.
  • Ability to ascend / descend stairs, ladders, ramps, and the like.
  • Ability to wear PPE correctly most of the day.
  • Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs.
  • Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation. Must be able to travel (if necessary).
  • Perform inspection of incoming materials using basic and advanced measurement tools
  • Perform quarantine activities including physical and electronic segregation, labeling, physical and electronic release
  • Perform second person verifications
  • Initiate NCRs with a thorough description of the nonconformance including target as well as discrepancy, quantity and standard used for rejection. Support investigation activities.
  • Complete first article inspections.
  • Perform and manage sorting activities to completion
  • Identify, initiate, and author WID updates
  • Support and / or manage validation testing, e.g. GR&R and program validations.
  • Develop first draft of Technical Review
  • Write validation protocols
  • Input data into MiniTab and work with Engineering on analysis of validation data
  • Initiate, author, and generate CO for IC documents
  • Support / interact with Materials Management, Engineers, Purchasing, and suppliers. This includes research activities and special projects.
  • Perform sweeps of warehouse area to ensure cGMP compliance with a lead auditor
  • . Review co-worker completed inspection records
  • Mentor technicians and specialists
  • Initiate routines and programs for metrology tools under engineer guidance; develop first draft of Tech Review
  • Coordinate activities for metrology tool calibration
  • Ensure compliance to Temporary Change Orders's; manage expiration status
  • Interpret and utilize SPC chart data
  • Analyze trends and participate in metrics development
  • Participate as a subject matter expert in internal and external audits of the Incoming Inspection team
  • Physical Requirements

  • Must be willing to submit to a color-vision test, though result of the test will not determine employment eligibility
  • Must be able to push, pull, bend, and / or lift at least 25 lbs, and may be required to lift up to 50 lbs., for extended periods of time on a daily basis.
  • Skills & Qualifications

  • Preferred specialized expertise such as IPC610 and / or IPC620 certified, GD&T background, problem solving, technical writing, black belt.
  • Demonstrated skill set and knowledge of inspection methodologies and techniques through competency testing during the interview process.
  • Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https : / / careers.biomerieux.com / or contact us at [emailprotected] .

    BioMerieux Inc. and its affiliates are Equal Opportunity / Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at [emailprotected] , or by dialing 711 for access to Telecommunications Relay Services (TRS).

    Create a job alert for this search

    Quality Specialist • Salt Lake City, UT, United States

    Related jobs
    Quality Improvement Specialist

    Quality Improvement Specialist

    First Step HouseSalt Lake City, UT, USA
    Full-time
    Quick Apply
    First Step House is hiring for a full-time Quality Improvement Specialist in.We help people build lives of meaning, purpose, and recovery,". Quality Improvement (QI) Specialist.Quality Improvement t...Show moreLast updated: 10 days ago
    • Promoted
    Quality Analyst / Principal Quality Analyst - 13175 •

    Quality Analyst / Principal Quality Analyst - 13175 •

    Northrop GrummanRoy, UT, US
    Full-time
    Quality Analyst Or Principal Quality Analyst.At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and...Show moreLast updated: 22 days ago
    • Promoted
    Quality Specialist (PCBA Inspection)

    Quality Specialist (PCBA Inspection)

    bioMerieux Inc.Salt Lake City, UT, United States
    Full-time
    The Quality Assurance (QA) department provides Quality support across various company departments.The department is organized into distinct subunits, consisting of Metrology, Document Control, Reag...Show moreLast updated: 3 days ago
    • Promoted
    Senior Supervisor, Quality Management

    Senior Supervisor, Quality Management

    Clearance JobsSalt Lake City, UT, US
    Full-time
    Supervisor is responsible for leading a team of inspectors and lower-level professionals in performing inspections and audits of purchased parts and units. This role requires the ability to interpre...Show moreLast updated: 30+ days ago
    • Promoted
    Restaurant Delivery - Start Earning Quickly

    Restaurant Delivery - Start Earning Quickly

    DoorDashMorgan, UT, United States
    Full-time +1
    DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day. As a Dasher, you’ll stay busy with a variety o...Show moreLast updated: 9 days ago
    • Promoted
    Experienced CDL-A Truck Driver - Earn $62,811 / Year + Home Time Options

    Experienced CDL-A Truck Driver - Earn $62,811 / Year + Home Time Options

    Hub GroupStockton, UT, United States
    Full-time
    Hub Group is Now Hiring CDL-A Drivers in North Salt Lake City, UT.Earn $62,811 per Year - Multiple Home Time Options - Excellent Benefits. Must have a valid CDL-A license and 1 year of experience.Lo...Show moreLast updated: 30+ days ago
    • Promoted
    Delivery Driver - Receive 100% of Customer Tips

    Delivery Driver - Receive 100% of Customer Tips

    DoorDashMorgan, UT, United States
    Full-time +1
    DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day. As a Dasher, you’ll stay busy with a variety o...Show moreLast updated: 9 days ago
    • Promoted
    Quality Specialist - Distribution

    Quality Specialist - Distribution

    Nature's BakerySalt Lake City, UT, US
    Full-time
    Quality Specialist - Distribution.As a Logistics Quality Specialist, you are responsible for ensuring that our soft-baked products produced, stored, and distributed across production facilities, co...Show moreLast updated: 16 days ago
    • Promoted
    Sr Quality Assurance Manager

    Sr Quality Assurance Manager

    BioFire DiagnosticsSalt Lake City, UT, US
    Full-time
    The Senior Quality Manager is responsible for leading teams of QA Technicians, Specialists and / or Supervisors that are focused on a specific Quality discipline in our West Warehouse.Their teams per...Show moreLast updated: 7 days ago
    • Promoted
    Restaurant Delivery - Receive 100% of Customer Tips

    Restaurant Delivery - Receive 100% of Customer Tips

    DoorDashMorgan, UT, United States
    Full-time +1
    DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day. As a Dasher, you’ll stay busy with a variety o...Show moreLast updated: 9 days ago
    • Promoted
    Sr. Specialist, Supplier Quality Management

    Sr. Specialist, Supplier Quality Management

    Cardinal HealthSalt Lake City, UT, United States
    Full-time
    What Quality Assurance / Supplier Quality Management contributes to Cardinal Health.Quality develops and implements quality policies, procedures, and processes to ensure products and services compl...Show moreLast updated: 3 days ago
    • Promoted
    Warehouse Quality Control Specialist

    Warehouse Quality Control Specialist

    TradeJobsWorkforce84045 Saratoga Springs, UT, US
    Full-time
    As a Warehouse Quality Control Specialist, you will be responsible for assisting with warehouse operations and ensuring smooth logistics, including : organize inventory and ensure items are stored p...Show moreLast updated: 30+ days ago
    • Promoted
    Assistant Manager

    Assistant Manager

    Top Stop Convenience StoresLake Point, UT, United States
    Full-time +1
    Welcome to the role of Convenience Store Assistant Manager! We are looking for an enthusiastic and organized individual to join our team and help provide exceptional service to our customers.As an ...Show moreLast updated: 30+ days ago
    • Promoted
    Sr Quality Specialist

    Sr Quality Specialist

    bioMerieux Inc.Salt Lake City, UT, United States
    Full-time
    The Quality Assurance (QA) department provides Quality support across various company departments.The department is organized into distinct subunits, consisting of Metrology, Document Control, Reag...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Specialist, Quality Assurance

    Senior Specialist, Quality Assurance

    Cardinal HealthSalt Lake City, UT, United States
    Full-time
    Senior Specialist, Quality Assurance – Pharmaceutical Private Label (Labeling Team).What Quality Assurance contributes to Cardinal Health. Quality develops and implements quality policies, procedure...Show moreLast updated: 2 days ago
    • Promoted
    Senior Specialist, Quality Relations

    Senior Specialist, Quality Relations

    Nightingale CollegeSalt Lake City, UT, US
    Full-time
    Senior Specialist, Quality Relations.The Senior Specialist, Quality Relations oversees training programs across Academic Operations, mentors junior specialists, and ensures alignment with organizat...Show moreLast updated: 1 day ago
    • Promoted
    Quality Inspector

    Quality Inspector

    TradeJobsWorkForce84043 Lehi, UT, US
    Full-time
    Quality Inspector Job Duties : Inspects and approves incoming materials by confirming specificati...Show moreLast updated: 30+ days ago
    Quality Engineer

    Quality Engineer

    cGxPServeSalt Lake, UT, United States
    Full-time
    Quick Apply
    Job Description : We are seeking a Quality Engineer with experience in the medical device industry to support quality assurance, regulatory compliance, and continuous improveme...Show moreLast updated: 4 days ago
    • Promoted
    Staff Quality Analyst

    Staff Quality Analyst

    Northrop GrummanSalt Lake City, UT, US
    Full-time
    At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and for generations to come.Our pioneering and i...Show moreLast updated: 30+ days ago
    • Promoted
    Restaurant Delivery - Flexible Onboarding

    Restaurant Delivery - Flexible Onboarding

    DoorDashMorgan, UT, United States
    Full-time +1
    DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day. As a Dasher, you’ll stay busy with a variety o...Show moreLast updated: 9 days ago