Job Title: Quality Assurance/Regulatory Affairs Manager
Type: Full time
Job Responsibilities: With support from the Richardson quality team, ensure the healthcare operations comply with ISO 13485 and regulatory requirements. Provide oversight for the development and maintenance of the quality program, processes and procedures that ensure compliance with standards and agency guidelines.
Essential Job Functions:
- Develop and manage the Quality Management System (QMS) for Healthcare CT tube manufacturing
- Create, implement and maintain policies and procedures to ensure full compliance with all regulatory requirements and policies including ISO13485 and 21 CFR Part 820.
- Lead the healthcare team in defining, developing and implementing quality best practices while, where appropriate, harmonizing with practices used across other global Richardson quality systems.
- Develop and track key metrics for quality system and team performance, drive improvement and communicate status.
- Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
- Lead audit and inspection preparation, resolution of audit and inspection findings.
- Ensures the quality assurance programs and policies are maintained and modified as needed
- Serve as the Healthcare Management Representative. Responsibilities include:
- Ensure Quality Management System processes are “Established, implemented and maintained”
- Report to Management on the QMS performance and where improvements are needed
- Ensure that everyone in the organization is aware of customer requirements
Qualification Requirements: Bachelor’s degree
Required Years of Experience:
- Effective verbal and written communication, analytical, influencing and interpersonal skills; must be able to communicate at all levels and across company lines
- 7+ years of medical device quality or regulatory experience
- 5+ years management experience
About Richardson Healthcare – A Division of Richardson Electronics: Richardson Electronics Healthcare provides high-value diagnostic imaging replacement parts, tubes, equipment, and technical support to hospitals, diagnostic imaging centers, medical institutions, independent service organizations, and more. We have a focused product selection of diagnostic imaging components and systems, as well as robust in-house manufacturing capabilities. In addition, we provide CT Service training, complete post-sale service, and support, including installation support, maintenance, troubleshooting, calibration, and conformance. For more information, visit us at www.rellhealthcare.com.
About Richardson Electronics: Richardson Electronics, Ltd. is a leading global manufacturer of engineered solutions, power grid and microwave tubes, and related consumables; power conversion and RF and microwave components including green energy solutions; high-value replacement parts, tubes, and service training for diagnostic imaging equipment; and customized display solutions. More than 60% of our products are manufactured in LaFox, Illinois, Marlborough, Massachusetts, or Donaueschingen, Germany, or by one of our manufacturing partners throughout the world. All our partners manufacture to our strict specifications and adhere to our supplier terms and conditions. We serve customers in the alternative energy, healthcare, aviation, broadcast, communications, industrial, marine, medical, military, scientific, and semiconductor markets. The Company’s strategy is to provide specialized technical expertise and “engineered solutions” based on our core engineering and manufacturing capabilities. The Company provides solutions and adds value through design-in support, systems integration, prototype design and manufacturing, testing, logistics, and aftermarket technical service and repair through its global infrastructure. More information is available at www.rell.com.
Diversity, Equity, Inclusion and Belonging Commitment
Richardson Electronics is an international company with offices located throughout the world. We promote a culture where our employees feel welcome, respected and empowered to grow. We understand, respect and value the similarities as well as the differences of our employees as we do in our own families. We strive to be nurturing and open-minded and to create a genuine feeling of belonging. Our commitment to diversity, equity, inclusion and belonging creates a great place to work and an environment where our employees, our customers and the communities we serve can reach their goals and connect. Our effectiveness in maximizing and bringing together the talents of people of different backgrounds, experiences and perspectives is key to our continued global success.
Equal Opportunity Employer/Veterans/Disabled
*Must be authorized to work in the US.
Required postings:
Family Medical Leave Act (FMLA)
https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Employer Polygraph Protection Act (EPPA) https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
Equal Employment Opportunity (EEO) Know Your Rights https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf
Invitation to Self-Identify
https://www.rell.com/webfoo/wp-content/uploads/2023/10/Invitation-to-Self-Identify.pdf
