Quality Assurance / Regulatory Affairs Engineer
Quality Assurance Duties:
- Facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders.
- Assure the quality of products and services, by creating, implementing pertinent quality control tests and inspections and engineering change order support.
- Assist with the creation, maintenance, and performance of Corrective Action Reports (CAR’s), Preventive Action Reports (PAR’s), and Process Change Orders (PCO’s).
- Participate in Supplier Management activities, as required.
- Provide Quality System guidance to his or her integrated product teams. Should be well versed in all aspects of Design Controls, Risk Management, and all associated processes, policies, procedures, and records. Ensure that the proper activities are completed in a timely manner, performed and documented correctly, and readily offers guidance and support to ensure Quality System compliance.
- Assume responsibility for completion of an annual share of Internal Quality Audits.
- Participate in the development of Management Review Presentations.
- Participate in 3rd party audit and inspection activities (ISO, FDA, etc.)
- Coordinate the creation, execution, and validation of all change orders.
- Initiate and maintain pertinent metrics, trending, and statistical analysis.
- Ensure that reasonable risk management controls are in place.
- Collaborate with engineering to determine and execute engineering DHF plans in support of regulatory submissions.
- Maintain superior knowledge of competitive technologies in addition to medical and technical developments related to the Company’s products.
- Carefully review Work Order fulfillment activities to ensure completeness of manufacturing and installation work activities and assigned rework activities.
- Review Device History Record (DHR) deliverables to ensure that production activities comply with Mandatory Device Master Record (DMR) requirements.
- Review all Engineering Change Requests and Engineering Change Orders to ensure sound engineering practice, effective and adequate design, product safety, and Quality System compliance.
Regulatory Affairs Duties
- Remain aware of new or updated regulations, laws, standards and other official enactments that may apply to the company.
- Provide detailed analysis, official recommendations, and gap analyses for new or revised enactments.
- Submit medical device adverse and field corrective actions reports and recall notifications.
- Ensure adequate compliance schemes associated with all regulatory compliance systems, as required by law.
- Author and coordinate all regulatory product clearance submissions.
- Assist in the submittal of registration applications. May assist in the preparation of IDE, 510(k), PMA, CE Mark, and other related regulatory filings.
- May interface with FDA and other regulatory agencies regarding regulatory submission strategy and approval reviews, as per company marketing plans.
- Establish and maintain a professional and credible image with FDA, and other regulatory agencies.
- Participate in cross-functional design review teams to review all product improvement Design Inputs and potential Defect Reports. Focus on recognizing potential impacts to health or device efficacy (“Safety Issues”), criticality assessment, to ensure the application of reasonable and required Risk Management, Verification and Validation, and adequate record-keeping practices.
- Bachelor’s of Science Degree in mechanical engineering, industrial engineering or other related science activity
- 3-5 years in a similar position responsible for medical device quality engineering duties.
- Seasoned Project Manager / Change Agent, Ability to effectively manage multiple projects at once.
- Proficient with basic office equipment, including computer workstation, electronic keyboard, and basic office use software applications
- Preferred experience with FDA Quality Systems Regulations, ISO standards, information privacy and security, environmental controls, and /or similar compliance schemes
- Prefer experience working in a regulated manufacturing environment as a Compliance Engineer (medical devices preferred) or equivalent
- Experience with medical device development under FDA Quality Systems Regulations, European Union Medical Device Directive (93/42/EEC), CE Marking process, and ISO standards.
- Demonstrated results improving quality within an ISO certified manufacturing environment.
- Excellent writing and interpersonal and public speaking communication skills.
- Proficient with Microsoft Office Suite.
- Excellent business and technical writing a must
Please send résumé to firstname.lastname@example.org