Sr Quality Systems Supv.

Medtronic•Juncos, PR

5d•Onsite

About The Position

A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. The Senior QA Supervisor oversees day-to-day quality assurance operations, provides leadership and coaching to QA team members, and ensures consistent application of quality processes. This role monitors quality performance, supports investigations and corrective actions, and collaborates with internal stakeholders to identify and manage quality risks. The Senior QA Supervisor also helps maintain compliance with company policies and regulatory standards while promoting a culture of quality, accountability, and continuous improvement. Responsibilities may include the following and other duties may be assigned.

Requirements

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.
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.

Nice To Haves

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

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.