Sr QA Manager- Complaints

Job Summary

Responsible for leading the quality and compliance for the customer complaints investigation process, ensuring compliance with applicable regulations and standards (e.g., QSR, GMP, ISO). The role involves leading cross-functional teams, managing the complaint resolution processes, and driving continuous improvement initiatives for assigned products and processes.

Job Description

Responsibilities:

1.    Compliance and Quality Oversight:

• Monitor and maintain compliance with applicable regulatory standards, including QSR (21CFR 820, 21 CFR 211), ISO 13485, ISO 14971, and MDR, for post-market surveillance activities.

• Act as a liaison with internal and external stakeholders, including leadership, suppliers, and manufacturing operations, to ensure quality and compliance.

2.    Complaint Management:

• Direct and manage the complaint process to ensure timely resolution and compliance with global regulatory requirements, with a specific focus on the complaint investigation process and ensuring robust and consistent complaint investigations are performed across the various product divisions.

• Maintain schedules and allocate resources to meet departmental quality and productivity standards.

• Foster a collaborative and transparent communication environment within the complaint handling team.

3.    Team Leadership:

• Lead and develop a team of managers, supervisors, and/or complaint Techs, providing coaching, feedback, and performance appraisals.

• Hire, train, and empower employees to achieve departmental goals while fostering teamwork and unity.

4.    Continuous Improvement:

• Identify and execute improvement projects to enhance the quality, efficiency, and effectiveness of post-market processes.

• Implement best practices and drive policy changes to optimize surveillance systems.

•  Implement and manage Corrective and Preventive Actions (CAPA) activities related to complaint investigations and the complaint investigation process.

5.    Data Analysis and Reporting:

• Analyze data from complaint handling and surveillance activities to identify trends, issues, and opportunities for improvement.

• Prepare reports for internal and external audits and provide leadership support during inspections.

6.    Cross-Functional Collaboration:

• Coordinate with divisional QA, manufacturing, and other stakeholders to resolve product or production quality issues.

• Develop effective communication strategies with internal and external stakeholders to ensure alignment on goals and expectations.

7.    Audit and Regulatory Support:

• Lead post-market activities during internal and external regulatory audits.

• Ensure thorough documentation and reporting to support compliance audits and inquires

Qualifications:

• Typically requires a Bachelor’s degree in Engineering, Science, or Technical Field.

• At least 5 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).

• At least 2 years of management experience.

• Depth of technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.)

• Proficiency in analyzing and reporting data and performing statistical analysis in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.

• Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.

• Advanced skill level in Microsoft Excel (for example: pivot tables and reporting, conditional formatting, tables, formulas, charting, etc.).

• Position requires travel up to 30% of the time for business purposes (within state, out of state and/or internationally).

Preferred Qualifications:

• At least 6 years of experience in post-market surveillance, complaint resolution, or quality assurance roles.

• Experience in industries such as Medical Device, Pharmaceutical, Food, or Cosmetic products.

• Experience managing people, including hiring, developing, and motivating teams.

• Strong understanding of complaint handling in a regulated environment.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, c