Quality Engineer
Medical Device
$70-$80K
We are working with a start-up looking to expand their Quality team and supporting a search for a Quality Engineer. This position is full-time onsite with a company who has recently secured significant funding and has large growth plans.
Duties & Responsibilities:
- Identify and implement quality improvement measures.
- Ensure all processes meet quality and ISO standards.
- Analyze and summarize data to prepare quality reports.
- Monitor production for compliance with control plans and customer requirements.
- Lead root cause analysis and CAPA initiatives.
- Manage supplier quality and process improvement data.
- Develop and oversee incoming inspection processes.
- Lead QA efforts with suppliers and handle nonconforming material.
- Investigate and resolve product complaints.
- Ensure timely and accurate quality inspections.
Position Requirements:
- Proficient in Microsoft Office.
- Strong communication and organizational skills.
- Able to work independently and as part of a team.
- BS in Engineering (or equivalent) with 3+ years in medical device QA.
- Deep knowledge of ISO 13485, FDA QSR, and GMP.
thomas.hatfield@acepartners.co.uk
