Quality Assurance Specialist
3 days ago
Job Title: Quality Assurance Specialist
Department: Quality Assurance
Reports To: Director of Quality
Position Summary:
The Quality Assurance Specialist plays a critical role in ensuring the quality and compliance of our medical devices. This individual will work closely with the engineering team to understand critical design characteristics and perform reviews to ensure products meet regulatory requirements. The successful candidate will help create, monitor, and improve quality system procedures to ensure efficient and effective compliance.
Duties & Responsibilities:
- Develop and implement quality improvement initiatives.
- Conduct process audits and ensure adherence to quality standards.
- Prepare and analyze reports to identify trends and areas for improvement.
- Collaborate with cross-functional teams to ensure timely delivery of products.
- Participate in root cause analysis and corrective action planning.
- Monitor and control supplier quality and process improvement functions.
- Develop and maintain quality-related documents and procedures.
- Establish and implement process control plans to ensure product quality.
- Provide quality-related support to the manufacturing floor.
- Monitor production processes for conformance to control plans and customer requirements.
- Develop and implement incoming inspection processes.
- Track nonconforming material and lead Material Review Board efforts.
- Interface with suppliers, contractors, and consultants to ensure quality compliance.
- Lead complaint investigations and ensure timely resolution.
- Ensure all quality inspections are conducted in a timely manner.
Position Requirements:
- Advanced proficiency in Microsoft Office products.
- Excellent communication and organizational skills.
- Ability to work independently and in a team environment.
- Process validation experience and a degree in engineering.
Education Requirements:
- BS in Engineering and a minimum of 3 years' experience in the regulated medical device industry.
- Excellent quality system knowledge and experience with ISO 13485 and FDA regulations.
This job specification outlines the essential duties and requirements for the Quality Assurance Specialist position. The successful candidate will be a key member of our quality team and will play a critical role in ensuring the quality and compliance of our medical devices.
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