QUALITY ENGINEER

Our client is a leading supplier of diverse, high precision manufacturing systems and components to leading clients in the medical device, aerospace and defense industries. They are seeking an experienced Quality Engineer to join their growing team.

In this exciting role as Quality Engineer, you will have responsibility for providing technical and quality systems expertise to support the Company in its quest to produce quality products that meet customer requirements as well as statutory and regulatory requirements. This role will also work to continually improve processes and support the quality management system while maintaining documentation to ensure that the Quality System is compliant to national and internal standards. This is a hands-on role where you will apply intensive, self-directed and diversified knowledge of engineering and quality conducting product strategy, and compliance to key industry standards.

Responsibilities:

• Document Control – write ISO documentation and maintain same within the facility, with regard to ISO 90001, ISO 13485, AS9100, and 21CFR part 820
• Process DCO’s, ECN’s, maintain revision control on documentation
• BOM Control – update BOM’s per ECN’s and other inputs, update quality planning accordingly
• Draft quality plans for new products and tests (IP Sheets)
• Conduct Internal Audits and issue audit reports as Lead Auditor
• Participate in 3rd party audits , including customer, Notified Bodies and Regulatory Agencies
• Answer customer Quality System audits and surveys, prepare for registrar audits
• Records retention for all products
• Prepare for semi-annual Management Reviews – coordinate preparations, contribute supporting info, write meeting minutes
• Prepare data and info for customer visits
• Maintain raw material certs, and the Material Certification List
• Initiate corrective action by drafting the CAR, PAR or SCAR
• Coordination and records maintenance for Cleanroom testing, raw materials and or finished products
• Preparation of data and reports to senior management upon request.
• Maintain Calibration system for equipment
• Create IQ/OQ/PQ Protocols and summary reports to provide to customers.
• Create and Execute Software Validations
• Utilize Minitab to populate data for part summary reports.
• Supervise / Support metrology and inspection resource

Qualifications:

• B.S. in Engineering discipline (preferably Bio-Medical, Mechanical or Industrial), or equivalent on-the-job experience (minimum 10 years)
• Experience in AS9100, Aerospace and Defense Manufacturing is required.
• Knowledgeable of document control methodologies is required.
• Thorough knowledge of ISO and cGMP requirements. i.e. AS9100, ISO9001, ISO13485
• Internal Auditor experience
• Use of standard and automated metrology equipment
• GD&T blueprint reading is required
• Knowledgeable in plastics processing, manufacturing, or tooling design environments is desirable
• ASQ certification is desirable

Take control of your career, help accomplish great things and see the results of your hard work! Apply now or contact Susan Kelly at 413-233-5484 to learn more.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Education:

• Bachelor's (Preferred)

Experience:

• Quality Engineering: 7 years (Preferred)

Work Location: In person

Please Note :
caminobluff.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, caminobluff.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.