Senior Quality Engineer

Responsibilities

• Maintain QMS and assure compliance with all relevant personnel.
• Manage, lead, coach, and mentor non-exempt and entry-level personnel.
• Identify and implement effective process control systems to support product development, qualification, and ongoing manufacturing.
• Lead in the implementation of assurance, process controls, and CAPA systems to meet or exceed internal and external requirements.
• Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Design and conduct experiments for process optimization and/or improvement.
• Participate and support internal stakeholders in Change Order management activities such as ECO, DCO for drawing and procedure revisions.
• Perform and report defects trend analysis, cost of quality, and period quality summaries.
• Support supplier quality activities including receiving inspections, assessment/selection evaluations, continual support, and SCAR generation throughout satisfactory closeout.
• Develop strategies and manage data collection & reporting of Key Performance Indicators (KPIs).
• Represent Quality function in Material Review Boards and Complaint Review Boards.
• Perform other related duties and assignments as assigned.

Requirements

• Bachelor’s degree in Engineering required. Advance degree preferred.
• Sound knowledge of, and experience implementing, quality systems, approaches, and tools.
• Knowledge of FMEA, Validations (IQ/OQ/PQ) and sampling strategies.
• Proficient in Microsoft Office and Minitab.
• Knowledge in DOE, MSA and SPC.
• Experience in ISO 13485 and/or 21 CFR 820.
• Working knowledge of Product Lifecycle and Change Control management – ECO, DCO.
• Thorough knowledge and understanding of NPD and manufacturing quality requirements.
• Solid communication and interpersonal skills.
• Demonstrated ability to achieve positive outcomes through direct interaction with Customers and Suppliers.

Other Desired Skills

• Prior medical device experience, preferably Class II or III medical device.
• Experience in Infinity QS – SPC tool.
• Experience in ERP system.
• Experience in facilitating customer/regulatory audits.
• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) or Six Sigma certification.
• Project management and supervisory skills.

Benefits

Employee Type: Salaried
Currency: USD
Salary Minimum: 85,000
Salary Maximum: 105,000
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. For more information on AMETEK's competitive benefits, please click here.

About the Role

AMETEK, Inc. is a leading global provider of industrial technology solutions serving a diverse set of attractive niche markets with annual sales over $7.5 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 22,000 colleagues, in 35 countries, that are grounded by our core values: Ethics and Integrity, Respect for the Individual, Inclusion, Teamwork, and Social Responsibility. AMETEK is a component of the S&P 500. Visit https://www.ametek.com/careers 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.