Senior Quality Engineer: Lead Quality & Compliance Initiatives

AMETEK, Inc.; Jackson (MN); On-site; USD 85,000 - 105,000; Full time

Job summary

AMETEK, Inc. is seeking a Senior Quality Engineer to ensure adherence to Quality Systems across development, manufacturing, and supplier quality. You will supervise 3–5 technicians/inspectors/auditors and drive QMS improvements.

The role focuses on implementing process controls, CAPA, and risk analysis with NPD and manufacturing teams. Strong knowledge of FMEA, IQ/OQ/PQ, ISO 13485, and 21 CFR 820 is required for success.

Qualifications

• Bachelor’s degree in Engineering required. Advanced 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.
• Working knowledge of ISO 13485 and/or 21 CFR 820.
• Experience in Product Lifecycle and Change Control management – ECO, DCO.
• NPD and manufacturing quality requirements.

Responsibilities

• Maintain QMS and be instrumental in assuring all appropriate personnel are in compliance with the QMS.
• Manage, lead, coach, and mentor non-exempt and entry level personnel.
• Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
• Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Work with NPD in developing risk analysis documentation – FMEA, Control Plan, and support test method and process validation activities.
• Design and conduct experiments for process optimization and/or improvement.
• Participate and support internal stakeholders in Change Order management activities like ECO, DCO for drawing and procedure revisions.
• Perform and report defects trend analysis, cost of quality, and period quality summaries.
• Participate in supporting quality disciplines, decisions, and practices. Represent Quality function in Material Review Boards and Complaint Review Boards.
• Support supplier quality activities, which includes receiving inspections, assessment / selection evaluations, continual support, and SCAR generation throughout satisfactory closeout.
• Develop strategies and manage data collection & reporting of Key Performance Indicators (KPI’s)
• Perform other related duties and assignments as assigned.

Skills

Quality systems

FMEA

CAPA

NPD collaboration

Problem solving

Leadership

Communication

Data analysis

Education

Bachelor’s degree in Engineering

Advanced degree preferred

Tools

Minitab

DOE

MSA

SPC

IQ/OQ/PQ

Job description

AMETEK, Inc. is seeking a Senior Quality Engineer to ensure adherence to Quality Systems across development, manufacturing, and supplier quality. You will supervise 3–5 technicians/inspectors/auditors and drive QMS improvements.

The role focuses on implementing process controls, CAPA, and risk analysis with NPD and manufacturing teams. Strong knowledge of FMEA, IQ/OQ/PQ, ISO 13485, and 21 CFR 820 is required for success.