Quality Engineer

Position Summary:

• The position of Quality Engineer is responsible for investigating product complaints, reporting results, maintaining returned product/component traceability, and maintaining Quality through implementation of GMP controls within the premises.
• The position will be responsible for recovering and quarantining non-conforming components or products from customer sites, decontaminating, and investigating the root cause of the failure.
• Investigations into the root cause of failures will be conducted in a timely manner, in collaboration with the Engineering and Product Support (Servicing) departments, and reported using the investigations processes.
• As the primary Quality resource for the US site activities will also include training, internal auditing, and monitoring compliance within the site.
• This role will report directly to the VP of Regulatory Affairs, North America, and will also receive direction from the Global Quality Manager located in the UK.

Major Responsibilities:

Under direction from the VP of Regulatory Affairs, North America, the Quality Engineer will be responsible for:

• Maintaining processes returning products/components for fault-finding investigations
• Investigating device issues, determining and reporting the root cause (in collaboration with the engineering department), and recommending corrective actions
• Working closely with the Complaints Manager to ensure timely and accurate reporting of complaint investigations
• Managing the day-to-day Quality Control of the site, including control of goods-in, maintenance of investigation equipment (including calibration), and maintaining accurate records of all activities
• Maintaining safe contamination control and quarantining of products where required
• Serve as the Quality Control point of contact for the US site and perform internal auditing of activities performed
• Working with other key stakeholders in relation to Quality Control topics

• This role may require up to 20% traveling

Skills and Experience:

• Working knowledge of FDA processes for medical device compliance
• Root cause analysis techniques
• The ability to write clear investigational plans and reports
• A good understanding of GMP compliance requirements in Quality Control
• An understanding of handling and decontamination of medical devices and equipment
• Ability to collect and analyze information to identify product and quality problems.
• Working knowledge of material, process, and product specifications, and inspection techniques.
• Experience in cross-functional collaboration with Manufacturing, Supply Chain, R&D, and Servicing departments
• Ability to work independently

Qualifications:

• A BS degree in biomedical or other engineering discipline, or equivalent experience  in the investigation of medical device component failures
• At least 3 years of experience working within FDA-regulated environments, including maintaining GMP and handling complaint investigations
• Internal auditor training a plus