Senior Quality EngineerLS Solutions • Lafayette, CO, US

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Senior Quality Engineer

LS Solutions • Lafayette, CO, US

19 hours ago

Job type

Full-time

Job description

Overview

Now Hiring! Validation, Automation Engineers, CSV Specialists, and Quality Engineers across the US for top pharmaceutical companies

Job Title : Sr Quality Engineer – Medical Device

Job Location : Lafayette, Colorado and North Haven, CT (Fully Onsite)

Type : W2 contract

Job Description -

Technical skills that are required for the role :

Risk Management (Hazard Analysis, DFMEA, UFMEA)
Design Verification Authoring and Execution

Education Required : Bachelors of Engineering, Years' Experience Required : 4

POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED :

Actively participate in product development cycle by reviewing mechanical / electro-mechanical project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.

Assesses overall product risk by facilitating the development of risk management tools such as the risk management plan / report, hazard identification, risk analysis chart, complaint analysis, etc.

Collect, analyze and interpret statistical data. Performs analyses and provide reports to management as required.

Contributes to the successful completion of Design and Process Validation initiatives by planning / reviewing validation and qualification activities, as required. This may include oversight to System / Sub-system Requirements, Critical to Quality Matrix, Process Flows, Control Plans, Measurement Systems Analyses and Process Capability Analyses.

Assisting with projects and assuring proper and consistent implementation of the quality engineering tools.

Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.

BASIC QUALIFICATIONS :

MUST HAVE : MINIMUM REQUIREMENTS :

EDUCATION REQUIRED : B.S. degree in Engineering, Math, Physical Science, or equivalent field with 5+ years of work experience in engineering or Quality

Preferred : M.S. degree in Engineering, Math, Physical Science, or equivalent field with 4+ years of work experience in engineering or Quality

YEARS OF EXPERIENCE :

Nice to Have : 6+ years of experience in a regulated industry (2+ years of experience can be substituted for an Advanced degree in a related discipline)

SPECIALIZED SKILLS OR EXPERIENCE :

Fundamental understanding of electro-mechanical designs and manufacturing processes to support designing, troubleshooting, improving and qualifying the design to ensure the sustainable manufacturing of medical devices both internal and external.

Experience in a regulated industry

Experience with Minitab or similar statistical analysis tools

Experience with Risk Management Tools

Good interpersonal skills; Ability to work effectively in a team environment and build strong working relationships.

Ability to work in a fast-paced environment; Ability to work well under pressure and maintain positive, enthusiastic attitude

Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects / tasks (Project Management skills).

High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning.

Nice to have :

ASQ Certified Quality Engineering (CQE)

Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements

Understanding of software and hardware interface.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Quality Assurance

Industries

Business Consulting and Services

Referrals increase your chances of interviewing at LS Solutions by 2x

Louisville, CO $104,000.00-$140,000.00 3 months ago

Longmont, CO $75,000.00-$100,000.00 4 days ago

Denver Metropolitan Area $80,000.00-$105,732.00 3 days ago

Westminster, CO $95,106.00-$161,680.00 3 days ago

Denver, CO $70,480.00-$109,768.00 3 weeks ago

Lakewood, CO $105,000.00-$132,000.00 2 weeks ago

Lakewood, CO $107,000.00-$133,800.00 2 weeks ago

Louisville, CO $135,000.00-$175,000.00 6 days ago

Boulder, CO $100,600.00-$125,500.00 2 weeks ago

Berthoud, CO $90,000.00-$120,000.00 3 weeks ago

Englewood, CO $80,000.00-$110,000.00 2 weeks ago

Westminster, CO $63,653.00-$108,210.00 1 day ago

Supplier Quality Engineer - Medical Devices

Lakewood, CO $115,000.00-$130,000.00 3 weeks ago

New Product Introduction (NPI) Manufacturing Engineer

Longmont, CO $100,000.00-$120,000.00 1 day ago

Golden, CO $80,000.00-$130,000.00 2 weeks ago

Longmont, CO $119,000.00-$203,000.00 21 hours ago

Denver, CO $80,000.00-$90,000.00 10 hours ago

Englewood, CO $60,000.00-$73,000.00 1 day ago

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Senior Quality Engineer • Lafayette, CO, US

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