Sr. Quality Engineer

Job Description

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POSITION SUMMARY

The Sr. Quality Engineer plans and conducts activities concerned with the quality assurance of industrial processes, materials, and products. The Sr. Quality Engineer will be responsible for ensuring the highest quality standards in our products and processes, working closely with cross-functional teams to develop, implement, and maintain quality assurance protocols that comply with regulatory requirements an industry standard. The Sr. Quality Engineer will possess a deep understanding of quality management systems, regulatory requirements, and risk management principles. The Sr. Quality Engineer will report directly to the Quality Engineering Manager.

Job Requirements:

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle.
• Performs quality engineering reviews of design documentation for compliance with stated requirements.
• Lead complex technical problems where analysis of situations or data requires an in-depth evaluation of various factors and solve a wide range of difficult problems in creative and effective ways.
• Develops or participates in establishing requirements for all verification and validation (design and process) activities.
• Apply state-of-the-art inspection and quality engineering/assurance techniques, procedures, instruments, equipment, theories, principles and concepts to products and processes.
• Leads development of Risk Management documentation.
• Leads/participates in data collection, analysis, trending and reporting on non-conformances and investigations to determine root cause, corrective and preventive actions.
• Mentors junior Quality Engineers as required.
• Participates in internal and external audits and inspections.
• Maintains process and software validation plans. Writes validation protocols. Facilitates completion of validation activities, performs data analysis, and writes the validation report.
• Prepares reports to communicate involvement and results of quality assurance and quality engineering activities.
• Prepares and presents technical and program information to team members and management.
• Directs technical and administrative workers engaged in quality assurance activities.
• Applies statistical analysis of data to evaluate the current process and process changes.
• Maintains a working knowledge of FDA GMP, ISO 13485 standards and other applicable standards.
• Documents data obtained during all quality assurance activities, consistent with company policies and procedures.
• Prepares reports to communicate involvement and results of quality assurance and quality engineering activities.
• Reviews all purchased products or components and provides input to the decision of whether to accept the product and future purchases from the vendor.
• Supports Regulatory Affairs with their activities related to submissions and notified body filings.
• Develop an understanding of Envista Business System (EBS) processes and tools and utilize in the execution of projects (i.e. Problem-Solving Process (PSP) and Visual Project Management (VPM)).
• Any duties or tasks assigned by Supervisor/Manager.

JOB REQUIREMENTS:

• Bachelor's degree (B. S.) in Engineering or a related field.
• 5 years of experience in quality engineering within medical device, pharma, biotech, healthcare or equivalent industry.
• FDA Quality System Regulation Part 820 and ISO 13485 experience.

SKILLS & QUALIFICATIONS:

• Master’s Degree in related field preferred.
• Certified Quality Engineer preferred.
• Effective interpersonal communication skills and able to interface with cross functional teams.
• Possess critical thinking skills and able to be assertive & challenge the process in a diplomatic manner.
• Strong verbal, written, and interpersonal skills (explains difficult or sensitive information; works to build consensus); able to explain technical terminology in layman’s terms to product development groups, peers, and senior management.
• Highly organized with a detail-oriented mindset
• Portray flexibility and multi-tasking in a dynamic environment with changing priorities.
• Adaptable to work with software-based development and automated processes.
• Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
• Works well in a cross-functional team; will speak up to provide guidance to other team members.
• Solves complex problems; takes a new perspective on existing solutions; exercises judgement based on the analysis of multiple sources of information.
• Ability to proactively influences designs to achieve product quality and reliability targets that meet or exceed customer expectations.
• Strong computers skills demonstrating a firm knowledge of Microsoft Office software (Word, Excel, PowerPoint, Outlook, and Microsoft Project). Able to type 50 WPM.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Working hours and shifts will vary and are dependent upon the work cycles required by business needs.
• The noise level in the work environment is usually moderate to loud.
• Due to the nature of product contents, careful handling and compliance to procedure and processes are required.
• Ability to stand and/or sit for long periods of time as required by business needs.
• Occasionally push, pull, lift and/or bend as required by business needs.
• Must be able to lift 25 pounds.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

$99,400 - $149,100

Operating Company:

Ormco

Ormco is a global leader and innovator of high-quality orthodontic products and solutions, including brackets and wires. For more than 60 years, our team has partnered with the orthodontic community to help create over 20 million smiles in more than 140 countries. We build trusted relationships. Each one is rooted in respect and understanding. We take that approach when we help orthodontists achieve their clinical and practice management objectives. We take the same approach when we help our team bring their personal best to work each day, ready to make a difference and reach their full potential.

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: compliance/posters/pdf/eeopost.pdf.

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.