Job Description:

JOB SUMMARY:

The Quality Assurance Manager is responsible for maintaining the quality system to ensure compliance with all regulatory and company standards and to contribute in enhancing product quality.

PRIMARY DUTIES & RESPONSIBILITIES:

• Serve as the Quality liaison responsible for the compliance of the local quality system and as the primary point of contact for regulatory body interactions.
• Lead and manage the Quality Assurance team to ensure compliance with all regulatory and company standards.
• Serve as the Quality representative during Policy Deployment (PD) meetings with the cross-functional site leadership team.
• Oversee the Quality Engineering team engaged in NPD and sustaining validation activities, ensuring that validation processes meet all necessary regulatory and procedural requirements.
• Support EU MDR Technical Documentation activities including evaluating Clinical Evaluation Reports/Post Market Surveillance Reports.
• Coordinate internal and external audits as the liaison, responding to audit findings with corrective actions to prevent recurrence.
• Manage the Corrective and Preventive Action (CAPA) system; ensure adequate root cause and corrective actions are identified and to evaluate the effectiveness of actions taken.
• Lead CAPA Review Board to review quality data inputs and propose actions.
• Coordinate Health Hazard Evaluations (HHE) with cross-functional team members to assess potential health risks, coordinate and take necessary field mitigation actions, if applicable.
• Supervise the customer complaint handling process to ensure timely evaluations for potential regulatory reporting.
• Support data trending practices to proactively identify and mitigate quality issues.
• Develop, maintain, and report on Quality KPI metrics
• Oversee the Material Review Board (MRB) process to ensure that nonconforming material is adequately evaluated for dispositions with records complying to regulatory and procedural standards.
• Oversee Supplier Quality activities to ensure that vendors are adequately approved, monitored, and issued corrective actions to resolve issues.
• Manage receiving and final inspection processes to confirm that all products meet quality specifications before distribution or progressing to subsequent production stages.
• Develop and maintain quality action plans to support ongoing improvement initiatives and compliance.

Job Requirements:

• Bachelor’s Degree in Engineering or related fields OR 7+ years of relevant Quality Assurance experience in lieu of education.
• 5+ years in related quality assurance/quality systems experience. Knowledge of FDA, ISO 13485, EU MDR, UKCA, and GMP regulatory requirements.
• 3+ years direct managerial/ supervisory experience.
• Quality engineering experience using quality tools and methodologies required.

REQUIRED SKILLS & ABILITIES:

• Strong verbal and technical writing skills in English to effectively communicate across all levels.
• Strong data analytical skills and ability to identify trends and provide recommendations to improve results.
• Effective time management and problem-solving skills.
• Effective project coordination and prioritization skills.
• Proficient interpersonal skills and ability to build and maintain good rapport and handle situations with confidence, tact, and resourcefulness.
• Ability to quickly learn computer business systems and software.
• High adaptability to changing priorities in a fast-paced environment required.
• Experience in a medical device or regulated industry preferred.

PREFERRED QUALIFICATIONS:

• Experience statistical tools & methodologies preferred.
• Intermediate with Microsoft Office Suite including Word, Excel, and Outlook preferred.

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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.

$97,900 – $181,700

Operating Company:

Orascoptic

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: http://www.dol.gov/ofccp/regs/ 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.