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Senior Manager of Quality Assurance
hace 2 meses
Job Summary
The Senior Manager of Quality Assurance will lead the quality teams, processes, and procedures to ensure quality controls and disciplines aimed at delivering products that meet customer requirements for safety, quality, and timeliness.
Key Responsibilities
- Lead and oversee product quality controls and disciplines that reduce risks and drive product quality in a mass manufacturing environment.
- Serve as the management representative and legal manufacturer representative for the site under their responsibility and when interacting with regulatory agencies.
- Ensure product compliance and regulatory requirements are met through procedures and practices that are aligned with current medical device regulations.
- Accountable for the site's quality lifecycle, including but not limited to design controls, supplier controls, manufacturing quality controls, corrective and preventive actions, customer complaints, internal and external audits, and regulatory agency visits.
- Support a multifunctional management and middle-management team in the understanding of regulatory requirements and their industry practices through ensuring processes are controlled and procedures are established and implemented within the framework of an established quality management system.
- Accountable for the training of all site employees in the required quality system and good manufacturing practices training.
- Communicate quality metrics and trends to site and upper management to accurately and timely recognize unfavorable trends or individual situations and escalate actions appropriately.
- Responsible for the effectiveness of the quality management system at their site.
- Through the knowledge of medical device regulation and its industry practice, oversee the day-to-day operations at their site to ensure good manufacturing practices are established, implemented, and maintained.
- Responsible for championing and communicating the organizations' quality policy and objectives.
- Lead periodic management reviews to drive actions that improve the organization's practices, processes, and culture of quality improvement.
Requirements
- Bachelor's degree in Science or Engineering.
- Master's Degree in Science, Engineering, or Business preferred.
- Minimum 10 years' experience managing in a world-class manufacturing environment.
- Bilingual English / Spanish.
- Lean and Six Sigma knowledge as it applies to a manufacturing setting.
- Statistics for Quality Control - use of statistical software such as Minitab.
- Must have requisite training or certification in medical device quality certifications such as ASQ CQE, CQA, RAPS or Six Sigma green or black belt.
- Adept in medical device regulations including but not limited to COFEPRIS, ISO 13485, QSIT, JPAL, MDSAP.
- Strong business communication skills both in English and Spanish.
- Ability to communicate 360 degrees to influence others including executive management personnel.
