Quality Engineer at Ametek, Inc. Quality Engineer at Ametek, Inc. in Bridgeport, Connecticut Posted in 15 days ago.

Type:

Full-Time Job Description:

Job Summary Responsible for meeting customer requirements for the manufacturing of surgicalinstruments 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 systemregulations. Develops and implements inspection/validationtechniques necessary to verify products meet requirements at earliest point inthe production process.

Specifies and implements new inspection equipment and instructs others inits proper use. Supports and implements systems in the areas of SPC, advanced quality, and design/development. Duties and Responsibilities Assists in the development and implementation of systems and processes that foster continuous improvement for product development and/ormanufacturing. Responsible for ensuring cell processes are correctly base-lined & controlled. Knownvariabilityis to be accounted for through selection & 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 released withuse 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. Maylead or verify effectiveness of corrective and preventive actions (CAPAs). Mayliaise directly with customer representatives. Supervise and trainpersonnel inthe inspection of raw materials, in-process and finished goods byusing statistical sampling techniques and precisionmeasuring instruments to check conformance to requirements. Verify that all productionprocedures have been followed and the records such as Device Master Records and Device History Records are maintained per FDA & customer requirements and Paragon Medicalrequirements. Design inspection/validation steps to be takenbyoperations 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 systemrequirements. Work in conjunction with Cell Leaders to ensure CNC Machinists are knowledgeable and competent inthe 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 ECN's and SCR's (product). Mayauthorize, 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. Education Preferred 4Year/ Bachelors Degree in Engineering or related field Experience 3-5 years experience withtight tolerance measurement systems inmachining applications, blueprint reading, GD&T, and a working knowledge of short-run process control methods, DOE, ISO standards, and FDA quality systemregulations. KSA's 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 attentionto detail required. Demonstrates problem solving skills, applying effective, data-driven, mistake-proofing concepts.

Strong project management skills required. Excellent follow-up skills required.

Individualis able to work withlimited supervision and actively participate ina team-oriented, continuous improvement, manufacturing environment. Physical Demands Frequent sitting, occasional standing, occasional walking. Use hand/fingers to grasp/pinch/grip Occasional climbing (stairs/ladders) or balancing. Occasional stoop, kneel, crouch, or crawl. Occasional perating of machineryand/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 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.