Senior Quality Systems Leader – Global QA Compliance

PRC Medtronic PR Operations Co.; Juncos (PR); On-site; USD 100,000 - 140,000; Full time

Job summary

Medtronic is seeking a Senior QA Supervisor to oversee day-to-day quality assurance operations, provide leadership to QA team members, and ensure consistent application of quality processes. The role monitors quality performance, supports investigations and corrective actions, and collaborates with internal stakeholders to identify and manage quality risks.

Responsibilities include developing and maintaining quality programs, ensuring regulatory compliance, leading audit preparation, and

Qualifications

• Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution.
• Requires advanced knowledge of job area obtained through advanced education combined with experience.
• Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 3 years of relevant experience, or an advanced degree with a minimum of 1 year of relevant experience).
• Nice to have: Problem solving Experience with regulatory agency Green belt certified Knowledge in problem solving techniques-Kepner tregoe, DMAIC. Knowledge in statistical techniques and Risk Management standards For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
• Co-ordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

Skills

Quality leadership

Audit & inspection

Regulatory knowledge

Process improvement

Coaching

Education

Bachelor's degree

Tools

Regulatory guidelines

Job description

Medtronic is seeking a Senior QA Supervisor to oversee day-to-day quality assurance operations, provide leadership to QA team members, and ensure consistent application of quality processes. The role monitors quality performance, supports investigations and corrective actions, and collaborates with internal stakeholders to identify and manage quality risks.

Responsibilities include developing and maintaining quality programs, ensuring regulatory compliance, leading audit preparation, and