This is a professional position with responsibilities for elements of the quality program. The Quality Engineer is experienced in multiple areas of medical device quality management and is capable of applying that experience and knowledge to proactively drive continuous improvement initiatives and work independently with minimal guidance from management. Serves as a technical reference and subject matter expert for colleagues with less experience. This position will provide leadership for improvement projects and will have the ability to solve problems affecting the quality system.
Key Responsibilities:
Responsible for planning, organizing and conducting duties related to elements of the supplier quality program including:
Qualification
Audits / Schedule
Scorecards and Performance Improvement via Key Metrics
Supplier Corrective & Preventive Action (SCAR) Process
Quality Business Reviews
Supplier Quality Agreements
Supplier Records Maintenance
Supplier Quality Manual/Procedure Development and Maintenance
Certification Process
Recognition Program
Incoming Inspection Management
Review Inspection Records
Inspection Records Maintenance
Ability to read and interpret assembly and component prints
Part inspection, including layout, in process, final, and receiving using all types of mechanical inspection
Basic knowledge of operating measurement equipment
Training of Inspectors
Non-Conformance Reports (NCR) and Material Review Board (MRB)
Coordinate review, support investigation, impact and corrective and preventative actions
Support and develop IQ, OQ, PQ protocols, documentation, validation
Support Calibration Program
Comply with the Quality Management System (QMS) and all applicable requirements for medical devices (i.e., 21 CFR 820 Quality System Regulation; ISO 13485:2016; ISO 14971:2019).
Utilize knowledge and expertise to identify, solve and document problems and risks within the Quality Program.
Support training (i.e. Supplier Quality Management, GMP's, Internal Auditing, FDA inspections, Quality Reporting, etc.).
Serve as a Subject Matter Expert (SME) for colleagues.
Conduct Internal Audits and support External Audits (i.e. FDA, UL, etc.)
Support QARA Management in conducting Management Reviews.
Support Customer Complaint Management, Internal Audit, Risk Assessment, Document Control, CAPA processes and Field Corrective Action (FCA).
Support data collection, quality report preparation and metric creation/deployment and performance process capability studies
Support Engineering design review for regulatory compliance, verification/ validation and activities in manufacturing to assure robust product vs customer requirements.
Support Engineering and Purchasing with historic supplier performance data for evaluation/selection on new product.
Good oral and written communication skills, ability to communicate effectively with all levels of staff and management, both internal and external
Capacity to work independently from general supervision (must be self-motivated once given direction/guidance)
Excellent organization skills with the ability to perform multiple tasks and obtain results working within strict time frames
Strong attention to detail
Education & Previous Experience:
Bachelor's degree in science or technical field
2-5 years in a manufacturing environment, of which 2+ years were in the Medical Device Industry
Experience working with a Supplier Quality Program and its elements.
Experience working in a Class I and Class II Medical Device environment.
Knowledge of medical device regulations/standards including 21 CFR 820 (QSR) and ISO - 13485:2016.
Knowledge of ISO 14971:2019 (Risk Management for Medical Devices).
Knowledge of Lean/Six Sigma process improvement approaches and techniques.
Compensation
Salary Minimum: Market
Salary Maximum: Market
Incentive: No
Disclaimer: Where a specific pay range is noted, it is a good faith estimate at the time of this posting. The actual salary offered will be based on experience, skills, qualifications, market / business considerations, and geographic location.
AMETEK, Inc. is a leading global provider of industrial technology solutions serving a diverse set of attractive niche markets with annual sales over $7.0 billion.
AMETEK is committed to making a safer, sustainable, and more productive world a reality. We use differentiated technology solutions to solve our customers' most complex challenges. We employ 21,000 colleagues, in 35 countries, that are grounded by our core values: Ethics and Integrity, Respect for the Individual, Inclusion, Teamwork, and Social Responsibility. AMETEK (NYSE:AME) is a component of the S&P 500. Visit www.ametek.com for more information.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 1 (866) 263-8359.
