Medical Device Quality Manager
1 month ago
At Advanced Sterilization Products, we are seeking an experienced Medical Device Quality Manager to lead our quality management initiatives and ensure compliance with regulatory standards.
The ideal candidate will have a strong background in medical device quality and a proven track record of implementing effective quality systems.
Responsibilities:
- Develop and implement quality management systems that meet or exceed regulatory requirements.
- Ensure compliance with FDA 21 CFR 820, ISO 13485, EU MD Directive/Regulations, China GSP & GMP, and other applicable regulations.
- Collaborate with cross-functional teams to identify and mitigate quality risks.
- Lead internal audits and quality system training programs.
- Maintain accurate records and reports on quality metrics and performance.
- Communicate effectively with stakeholders, including regulatory agencies, customers, and internal teams.
- Analyze data and provide insights to inform quality-related decisions.
- Continuously improve quality processes and procedures to drive business growth.
Requirements:
- Bachelor's degree in a related field (e.g., quality assurance, engineering, biology).
- Minimum 5 years of experience in medical device quality or a related field.
- Demonstrated knowledge of regulatory standards and regulations.
- Excellent communication and leadership skills.
- Ability to work in a fast-paced environment and adapt to changing priorities.
Compensation: We offer a competitive salary of $120,000 - $150,000 per year, depending on experience. Additionally, we provide comprehensive benefits, including health insurance, retirement plan, and paid time off.
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