Quality Assurance Manager

Job Description:

Provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards. May conduct quality assurance tests to ensure product specifications are met. May review, investigate, resolve and report on quality discrepancies. May develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards. May monitor, investigate, and report on customer complaints. May obtain the necessary quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development. May lead audit and inspection preparation, resolution of audit and inspection findings. May have frequent interaction with other functional areas and operating entities.

This Job is also suitable for persons with disabilities; attendance required – disabled-accessible building.

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Essential Duties and Responsibilities:

• Serve as the Quality liaison responsible for the compliance of the local quality system.

• Lead and manage the Quality Systems team to ensure compliance with all regulatory and company standards.

• 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.

• Analyzes, develops, and implements quality assurance strategies in collaboration with various departments to support strategic initiatives.

• Ensures processes and procedures are followed related to change control, investigations, post market surveillance, corrective/preventive action, and validation to ensure compliance and timely and accurate completion of tasks.

• Manage receiving and final inspection processes to confirm that all products meet quality specifications before distribution or progressing to subsequent production stages.

• Coordinate Health Hazard Evaluations (HHE) with cross-functional team members to assess potential health risks.

• 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.

• Ensure that nonconforming material is adequately evaluated for dispositions with records complying to regulatory and procedural standards.

• Drive continuous improvement initiatives to enhance quality and efficiencies.

• Develop and maintain quality action plans to support ongoing improvement initiatives and compliance.

• Manage document control processes to ensure accuracy and completeness of quality records.

• Provide quality training to staff to promote a culture of quality across the organization

Job Requirements:

Education and Experience:

• Bachelor’s Degree in engineering or related field.

• Minimum 5 years in related quality assurance/quality systems experience.

• Minimum 3 years direct managerial/ supervisory experience.

• Familiarity with manufacturing processes and operations required.

Required Skills and Abilities:

•  Knowledge of FDA, ISO 13485, EU MDR, UKCA, and GMP regulatory requirements.

•  Strong verbal, written, and technical writing skills in English and Czech to effectively communicate across all levels.

•  Strong data analytical skills and ability to identify trends and provide recommendations to improve results required.

• Effective project coordination and prioritization skills are required.

•  Good interpersonal skills and ability to build and maintain good rapport and handle situations with confidence, tact, and resourcefulness required.

• Ability to quickly learn computer business systems and software required.

•  Intermediate with Microsoft Office Suite including Word, Excel, and Outlook preferred.

• Ability to adapt to changing priorities in a fast-paced environment required

Operating Company:

Kerr

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.