What are the responsibilities and job description for the Senior Quality Engineer position at BioTalent?
Senior Quality Engineer | Medical Device
I'm partnering with a medical device manufacturer seeking a Senior Quality Engineer to support and improve quality systems across CAPA, supplier quality, complaint handling, audits, validation, risk management, and continuous improvement initiatives. This role plays a key part in ensuring product quality, regulatory compliance, and patient safety throughout the product lifecycle.
Responsibilities
- Lead CAPA investigations, root cause analysis, and corrective actions.
- Support supplier quality activities, including audits and supplier corrective actions.
- Investigate complaints, nonconformances, and product quality issues.
- Maintain compliance with FDA regulations, ISO 13485 requirements, and internal quality systems.
- Participate in internal, supplier, customer, and regulatory audits.
- Support risk management, validation, and continuous improvement initiatives.
- Partner with Manufacturing, Engineering, Operations, and Regulatory teams to resolve quality challenges and improve processes.
What We're Looking For
- 5 years of Quality Engineering experience within the medical device or other regulated manufacturing industry.
- Experience with CAPA, complaint investigations, supplier quality, audits, and quality systems.
- Experience working within FDA and/or ISO 13485 regulated environments.
- Familiarity with risk management, validation activities, and Design Controls.
- Bachelor's degree in Engineering, Science, or a related discipline preferred.
Salary : $125,000 - $130,000