Orascoptic Quality Assurance Manager (On-Site Madison, WI)

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 ha