Senior Quality Engineer

Select how often (in days) to receive an alert:

Business Unit:
Advanced Medical Components

As the Senior Quality Engineer you will be responsible for meeting customer requirements for the manufacturing of surgical instruments and implementing instrument delivery systems from receiving raw material to the shipping of finished goods. You will support and enforce the development of internal systems and procedures to meet ISO standards and FDA quality system regulations. You will develop and implement inspection/validation techniques necessary to verify products meet requirements at earliest point in the production process.

You will specify and implement new inspection equipment and instruct others in its proper use. You will support and implement systems in the areas of SPC, advanced quality, and design/development.

• 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. Known variability is to be accounted for through selection and frequency of inspection, sampling plans, or implementation of SPC.
• Completes the implementation and performance of gage R&R, process capability studies, design of experiments, and summaries as required to improve quality and to provide required deliverables to customers.
• Ensures processes are released with the use of SPC where applicable and/or promote the utilization of SPC.
• Provides SPC & ongoing monitoring of SPC.
• Investigates deviations, OOS, complaints, returns, recalls, and field alerts.
• Supports the Material Review Board (MRB) 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.
• Verifies that all product instructions have been followed and records such as Device Master Records and Device History Records are maintained per FDA & customer requirements and Paragon Medical requirements.
• Designs inspection/validation steps to be taken by operations at the point of manufacture and integrates these steps into the manufacturing instructions.
• Responsible for creating, implementing and improving quality systems and procedures for meeting ISO 13485, FDA and customer quality system requirements.
• Works in conjunction with Cell Leaders to ensure CNCM 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.
• Provides day-to-day oversight of quality including batch testing, inspection, calibration, environmental monitoring, qualification, document review, etc.
• Creates and supports ECNs and SCRs (product).
• May authorize, 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 Bachelor’s Degree in Engineering or related field

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

• Strong written and verbal communication skills.
• Excellent customer teaming and interpersonal aptitude.
• Strong computer skills including excellent Word, Excel, PowerPoint, and Minitab skills.
• Excellent organizational skills and attention to detail required.
• Demonstrates problem solving skills, applying effective, data-driven, mistake-proofing concepts.
• Strong project management skills required.
• Excellent follow‑up skills required.
• Individual is able to work with limited supervision and actively participate in a team-oriented, continuous improvement, manufacturing environment.

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

Employee Type:
Salaried

Salary Minimum: $90,000

Salary Maximum: $115,000

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 .

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,…