THE FOLLOWING QUALIFICATIONS ARE REQUIRED FOR CANDIDATE CONSIDERATION:
- A Bachelor's Degree in Engineering or related technical field and a minimum of 5 years’ experience in a Quality Systems role
- Strong working knowledge of ISO 13485 and FDA Quality System Regulation (QSR) 21 CFR Part 820
- Experience successfully leading cross functional teams to execute against a timeline
- Demonstrated conflict management skills
- Excellent interpersonal skills
- Experience in change control and change management
- Demonstrated organizational and presentation skills
- Accurate and attentive to detail
- Demonstrated technical writing skills
- Strong working knowledge of Microsoft Excel, PowerPoint, Visio, and Word
THE FOLLOWING QUALIFICATIONS ARE DESIRED BUT NOT REQUIRED:
- Experience in medical device design and development
- Working knowledge of Pilgrim SmartSolve eQMS; Experience leading QMS design and/or ISO registrationCQE, or equivalent certification.
- Familiarity with quality engineering concepts including:
- Risk assessment (DFMEA, PFMEA, UFMEA, etc.); Process capability and statistical process control; Tracking and trending of quality data
- Root cause analysis, corrective and preventive action, and effectiveness verification; Systems, methods, or product validation, or qualification
We are currently seeking a Medical Products Quality Engineer to support Quality Management System (QMS) conversion efforts in support of ISO 13485:2016 conformance.
The Quality Engineer reports to the Quality System Manager and plans, directs, and implements appropriate QMS program changes to ensure conformance to ISO 13485:2016 to effectively and efficiently assure the quality of medical device and combination products from early feasibility and concept development through design and development, verification and validation, and clinical trial.
- Lead a cross-functional core team responsible for the remediation of Quality Sub-System(s) per ISO 13485:2016:
- Evaluate conformance gaps
- Establish vision and plans for future-state and present to stakeholders and top management; Develop timelines and hold team accountable
- Communicate status to stakeholders, management, and resource groups; Create/revise appropriate documentation; Verify, route, implement changes to Quality System; Train staff to the updated requirements; Follow-up to assure effectiveness of training; Monitor/audit results
- Supports audit(s): Aid in explanation of QMS conformance; Assist in evaluation, investigation, response, and corrective action for findings