Quality Systems Specialist
3 days ago
About Us: Sunrise Medical is committed to improving people's lives by providing innovative, high-quality mobility products and services that exceed customer expectations. We are a world leader in the development, design, manufacture, and distribution of manual and powered wheelchairs, mobility scooters, and both standard and made-to-order seating and positioning systems.
Job Description: As a Senior Quality Engineer at Sunrise Medical, you will be responsible for implementing quality systems elements in accordance with FDA Quality Systems Regulations and ISO 13485 standards. You will work closely with engineering and operations teams to ensure that all quality and regulatory issues are addressed.
Responsibilities:
- Provide direct support and oversight of product and manufacturing engineering activities
- Develop and implement quality management systems in accordance with regulatory requirements
- Lead a quality staff and manage internal audit requirements and process validation requirements
- Collaborate with cross-functional teams to identify and address quality and regulatory issues
Requirements: To be successful in this role, you will need to have a Bachelor's degree in Mechanical Engineering or a related field, as well as four plus years of relevant experience. Knowledge of ISO 13485, 21 CFR 820, and ISO 14971 is preferred. Certified Quality Engineer and/or Six Sigma Black Belt Certification is a plus.
Benefits: At Sunrise Medical, we offer excellent health benefits plans, life insurance, 401(k) with company match, generous vacation and paid sick time-off, paid holidays, Employee Assistance Program, Employee Resource Groups, wellness programs and benefits, and Education Reimbursement Program.
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