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Job Detail
| Job Title: |
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Quality - Senior QA Engineer (Medical Devices/Plastics) #43328 |
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| Location: |
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Manchester, NH |
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| Specialty: |
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Quality |
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| Description: |
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OPPORTUNITY FACTS: Our client company is a global organization dedicated to the innovative support of healthcare providers with a broad range of medical solutions. Their reputation for excellence spans nearly two hundred years!
POSITION DESCRIPTION: We are seeking talent with strong leadership in quality engineering for manufacturing and product development. This position requires experience in compliance with FDA 21CFR Part 820, ISO 13485, and internal procedures. Duties include:
• Directing quality activities in manufacturing such as inspection methods and Material Review Board (MRB);
• Supporting product development such as design change and review, quality planning, risk evaluation, and validation;
• Supervising QA inspectors, if needed;
• Coordinating Corrective and Preventive Action (CAPA) for customer, internal and vendor related needs;
• Auditing internal and vendor processes and procedures;
• Participating in Continuous Improvement Projects for processes and business systems;
• Developing training programs for inspection and engineering;
• Representing the company during customer or regulatory audits.
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| Experience: |
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• 5+ years of QA engineering in a medical device manufacturing facility;
• Must have plastics experience;
• Must have ASQ certification;
• Must have experience in compliance with FDA 21CFR Part 820, ISO 13485, and internal procedures;
• Knowledge and skills in regulatory cGMP, QSR, ISO;
• Statistical skills: DOE, SPC, Reliability, Gage R&R;
• Experience with risk analysis methodologies;
• Experience developing training programs;
• Good communication, negotiation and problem solving skills;
• Computer literate: MS Word, Excel, Access, PowerPoint, Mini-tab.
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| Salary: |
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$70-90K + Bonus + relocation |
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| Education: |
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4-year degree required; technical discipline preferred. |
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| Skills: |
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Quality Assurance Engineer, Medical Devices, Plastics, QA engineering, ASQ certification, cGMP, QSR, ISO, DOE, SPC, Reliability, Gage R&R, risk analysis methodologies, training, negotiating, problem solving, MS Word, Excel, Access, PowerPoint, Mini-tab |
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| Relocation: |
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Yes |
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| Relocation Detail: |
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| Date Posted: |
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| Submit Resume: |
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Click here to submit your resume |
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