Operations Quality Control Senior Manager

As a Sr. Manager, Operations Quality Control, you will be responsible for leading Manufacturing Quality and Supplier Quality activities within a fast-paced medical device environment. You will leverage your deep medical device experience (hardware and software) and leadership to develop, implement and support efficient and compliant processes related to device manufacturing including receiving inspection, process qualification, NCR resolution, Material Review Board (MRB), CAPA, Mfg. line testing, Supplier Quality, etc. The ideal candidate is skilled at team building and leading, demonstrates a solution-oriented, continuous improvement mindset, is effective in helping teams navigate from ambiguous situations into positions of clarity, is a proficient problem solver, and exhibits a relentless passion for patient safety and quality.

This role is remote but may involve occasional onsite collaboration at our Best Buy Health office. For this role, you must be located within a commutable distance to Boston MA, San Antonio TX, Novi Michigan, Reno NV, or Richfield MN. Current Best Buy Health and Best Buy employees are encouraged to apply, regardless of location. The recruiter or hiring manager will provide more details during the hiring process.

What You’ll Do

• Lead and manage a team, ensuring efficient and compliant production of medical devices (hardware and software).
• Develop, implement, and maintain production and process supplier control procedures in accordance with ISO 13485, FDA QSR 820, EU MDR 2017/746 requirements.
• Oversee the implementation of quality control procedures throughout the entire manufacturing and supplier process.
• Manage and maintain inspection, measuring, and test equipment, ensuring proper calibration and functionality (FDA QSR 820.72).
• Oversee and manage process validation activities to ensure the effectiveness of manufacturing and supplier processes (FDA QSR 820.75).
• Develop and implement procedures for receiving, in-process, and finished device acceptance activities (FDA QSR 820.80).
  
  

Basic Qualifications

• Minimum of 7 years of experience in manufacturing and supplier management within the medical device industry, with experience in managing both hardware and software production (a plus).
• For this role, you must be located in a commutable distance to either Boston Ma, Minneapolis MN, San Antonio TX, or Novi Michigan office. Current Best Buy Health and Best Buy employees are eligible regardless of location.
  
  

Preferred Qualifications

• Proven track record of successfully leading and managing a supplier team to ensure quality and compliance with regulatory requirements.
• In-depth knowledge of production, supplier, and process controls for medical devices, including ISO 13485:2016 section 7.5 (Production and service provision) and FDA QSR 820 (subparts covering production controls, inspection & test equipment, process validation, acceptance activities, and acceptance status).
• Experience with implementing and maintaining effective quality control procedures throughout the manufacturing process and supply chain.
• Experience with managing and calibrating inspection, measuring, and testing equipment in accordance with FDA QSR 820.72.
• Experience with managing non-conformance issues and implementing corrective and preventive actions (CAPA).
• Willing to travel up to 10% of the year.
  
  

What’s In It For You

We’re committed to helping our people thrive at work and at home. We offer generous benefits that address your total well-being and provide support as you need it, especially key moments in your life.

Our Benefits Include

• Competitive pay
• Generous employee discount
• Physical and mental well-being support
  
  

About Us

Best Buy Health aims to enrich lives through technology and meaningful connections. We do that by focusing on consumer health products that help people live healthier lives, device-based emergency response services for the active aging population and virtual care offerings that help connect patients to physicians

Best Buy Health is an Equal Opportunity Employer that complies with Section 503 of the Rehabilitation Act and Vietnam Era Veterans' Readjustment Assistance Act (VEVRAA). We are committed to equal employment opportunity for all applicants and employees. Learn more about our commitment HERE

Reasonable Accommodation

Best Buy Health will make reasonable accommodations for employees and applicants for their religious beliefs and practices, mental or physical disabilities, and pregnancy, childbirth and related conditions, and otherwise as required by applicable law. If you need a reasonable accommodation in the application process - to access job postings, to apply for a job, for a job interview, for pre-employment processes or with the onboarding process - please contact Talent Acquisition at talent.acquisition@bestbuy.com.

To learn more, view the “Know Your Rights” poster HERE

Position Type: Full timePandoLogic. Keywords: Quality Control / Quality Assurance Manager, Location: Boston, MA - 02108