Job Quality Engineer

Quality Engineer

Responsible for meeting customer requirements for the manufacturing of surgical instruments and implants or instrument delivery systems from receiving raw material to the shipping of finished goods. Supports and enforces the development of internal systems and procedures to meet ISO standards and FDA quality system regulations. Develops and implements inspection / validation techniques necessary to verify products meet requirements at earliest point in the production process.

Duties and responsibilities include :

• Assists in the development and implementation of systems and processes that foster continuous improvement for product development and / or manufacturing.
• Responsible for ensuring cell processes are correctly based and controlled.
• Completes the implementation and performance of gage R&R, process capability studies, design of experiments, and summarizes as required to improve quality and to provide deliverables to customers.
• Ensures processes released are thus used and / or promotes the utilization of SPC where applicable.
• Provides SPC & ongoing monitoring of SPC.
• Investigates deviations, OOS, complaints, returns, recalls, and field alerts.
• Supports the Material Review Board for internal non-conformances and customer returns.
• May lead or verify effectiveness of corrective and preventive actions (CAPAs).
• May liaise directly with customer representatives.
• Supervises and trains personnel in the inspection of raw materials, in-process, and finished goods by using statistical sampling techniques and precision measuring instruments to check conformance to requirements.
• Verify that all product procedures have been followed and the records such as Device Master Records and Device History Records are maintained per FDA & customer requirements and Paragon Medical requirements.
• Design inspection / validation steps to be taken at the point of manufacture and integrate these steps into the manufacturing instructions.
• Responsible to create, implement and improve quality systems and procedures for meeting ISO 13485, FDA and customer quality system requirements.
• Work in conjunction with Cell Leaders to ensure CNC machinists are knowledgeable and competent in the use and care of sensitive measuring equipment and related requirements such as calibration, recording of data, expected variability, etc.
• Provide day-to-day oversight of quality including batch testing, inspection, calibration, environmental monitoring, qualification, document review, etc.
• Creates and supports ECs and SCRs (product).
• May author, initiate, and / or approve product and process changes.
• Supports both internal and external audits of all corporate quality systems and demonstrates compliance through objective evidence.

Preferred 4 Year / Bachelors Degree in Engineering or related field.

Experience

3-5 years experience with tight tolerance measurement systems in machining applications, blueprint reading, GD&T, and a working knowledge of short-run process control methods, DOE, ISO standards, and FDA quality system regulations.

KSAs

Physical Demands

Frequent sitting, occasional standing, occasional walking. Use hand / fingers to grasp / pinch / grip. Occasional climbing (stairs / ladders) or balancing. Occasional stoop, knee, crouch, or crawl. Occasional operating of machinery and / or hand power tools.

Compensation

Employee Type : Salaried

Salary Minimum : $90,000

Salary Maximum : $105,000

Incentive : 1289

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.

For more information on AMETEK's competitive benefits, please click here.

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 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.