Regulatory Affairs / Quality Assurance (RA/QA) Engineer
Job duties and responsibilities:
The RA/QA Engineer is responsible for the establishment and maintenance of the Mevion Quality System, called the Mevion Business Management System (BMS). All RA/QA employees shall seek to develop a quality- and results-centric company culture that drives customer satisfaction, employee satisfaction, meaningful regulatory compliance, and continually improving operational excellence. This shall be done by inspiring employees to achieve to their potential, fostering the achievement of company goals by organized teamwork, and demonstrating operational excellence via management leadership to support company quality policies and goals and maintain operations that efficiently and effectively surpass strategic business planning objectives.
The RA/QA Engineer is also responsible for identifying, evaluating, and ensuring meaningful compliance with all applicable laws, regulations, and standards. Efforts to ensure company compliance shall be inherently established within the company’s Quality System, the Mevion Business Management System.
Supporting Quality Assurance:
The RA/QA Engineer shall follow the guidance of RA/QA Management and help other specialized organization functions understand and fulfill their obligations to meet quality objectives, systemic responsibilities, and customer requirement policy, as defined by Executive Management in the Mevion Quality Policy.
As part of the maintenance of the Mevion Business Management System, the RA/QA Engineer shall partake in some or all of the following responsibilities:
The RA/QA Engineer shall follow the Guidance and direct other specialized organizational functions understand and fulfill their obligations to meet quality objectives, systemic responsibilities, and customer requirement policy, as defined by Executive Management in the Mevion Quality Policy.
As part of the maintenance of the Mevion Business Manage System, the RA/QA Engineer shall partake in some or all of the following responsibilities:
- Publicize the Quality Policy of the MEVION BMS and promote applicable company culture.
- Routinely pursue more efficient and effective operations (continual improvement).
- As an MRB facilitator, the Quality Engineer shall facilitate the efficient and effective processing of Nonconforming Material Reports and Rework Orders.
- Assure the quality of products and services, by creating, implementing, the MEVION BMS, including pertinent quality control tests and inspections and engineering change order support.
- Assist with the creation, maintenance, and performance of BMS change management tools: 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. He or she shall be well versed in all aspects of Design Controls, Risk Management, and all associated processes, policies, procedures, and records. He or she shall 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.
- Shall carefully review Work Order fulfillment activities to ensure completeness of manufacturing and installation work activities and assigned rework activities.
- Shall 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.
Supporting Regulatory Affairs:
The RA/QA Engineer shall ensure continual visibility over the development and promulgation of legal and regulatory enactments, identify company improvements or activities necessary to ensure compliance, and ensure that the company establishes controls and/or completes necessary activities to ensure compliance. Further, the RA/QA Engineer shall also conduct reviews of all and all future target markets to ensure knowledge and fulfillment of establishment registration, device licensing, surveillance, adverse event and corrective action reporting, translation, product standards, and all other requirements necessary to support import, sales, distribution, installation, and support in all chosen distribution markets.
Duties included but not limited to:
- 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 the FDA, and other regulatory agencies.
- Shall participate in cross-functional design review teams to review all product improvement Design Inputs and potential Defect Reports. RA/QA Engineers shall 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.
- All other duties, as assigned.
Minimum educational, training, and experience qualifications:
- A 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.
- Regular practice of RA/QA skills and activities.
- Seasoned Project Manager / Change Agent, Can 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 in 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 submit resume to: firstname.lastname@example.org
Mevion Medical Systems, Inc. offers competitive compensation and benefits.
Mevion Medical Systems, Inc. is an equal opportunity employer.