Quality Engineer at Ametek, Inc. in Mount Prospect, Illinois

Job Description:

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)

Quality Key Metrics Reporting Internal/External/Supplier

Develop Work Instructions

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).

Preferred

• Experience in conducting supplier audits.
• Experience supporting external audits (i.e., FDA Audits, Customer Audits, Corporate Audits, UL, etc.).
• Certifications preferred - i.e., Internal Quality Auditor, Certified QE, Risk Management, Certified Six-Sigma Black Belt.
• 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.

Nearest Major Market: Chicago

Apply Now