QA Engineer

The Position Includes:

• Work with the leadership team to ensure quality initiatives support the company’s goals and quality objectives.
• Maintaining the quality initiatives to ensure compliance with quality and regulatory standards including ISO 13485:2016, FDA Quality System Regulations, Canadian Medical Device Regulations, European Medical Device Regulations and Brazil Medical Device Regulations.
• Responsibility for all customer complaints activities. 
• Monitor and collect QMS related data for analysis and presentation at management reviews.
• Prepare, verify, and maintain preventative and corrective action reports and non-conformances.
• Assist for internal/external audits and take appropriate actions in response to any non-conformances. 
• Assist train employees on elements of the QMS.
• Assist the document control system including issuing document numbers and processing document-related change orders.
• Assist project teams in product development activities including coordinating planning activities, monitoring the release of documents and phase transition activities including design reviews and other verification and validation activities.
• Assist project teams in performing risk management activities as part of product development and post-market risk activities.

Requirements:



• Bachelor's Degree (BA/BS) in Engineering or Life Sciences discipline required.
• Minimum four (4) years of experience in Medical Devices or other health care regulated industries required.
• Experience with FDA, Health Canada, EU, Notified Body, and/or international regulators is strongly preferred.
• Experience with successful preparation, submission, and approval of US 510(k) and/or international documents and registration and marketing of medical devices worldwide required.
• Ability to clearly communicate and write reports and business correspondence in English.
• Knowledge of Quality System Requirements and International Technical Standards.
• Experience in supporting international registrations.
• Expert knowledge of US, EU MDR, and/or international medical devices regulations, guidelines, and policies.
• Experience in the design control process.
• Expert at compiling medical device document.