Senior Manager, Production & Process Control

Job title: Senior Manager, Production & Process Control

Company: Best Buy Health


Job description: As a Sr. Manager, Production and Process 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 eligible, which means you would work virtually from home or another non-Best Buy Health location.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).

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 youWe’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 usBest 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.Position Type: Full time

Expected salary:

Location: Edinburgh

Job date: Sun, 09 Feb 2025 08:38:38 GMT

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