Quality Engineer 04080

LOCATION: South Carolina and Massachsuetts

INDUSTRY: Injection Molding

SPECIFIC DUTIES, ACTIVITIES, AND RESPONSIBILITIES: Primary responsibilities include ensuring regulatory compliance of the facility and quality system in accordance with 21 CFR 820/210/211, ISO 9000 and customer-specific requirements. Generate and review initial and ongoing Device Master Record, Design History File, validation protocols (Equipment and Facility) and other project support documentation. Promote a plant-wide cGMP-compliance culture. Additionally, determine compliance and corrective action needed to maintain all regulatory standards. Assist the Quality Manager, Corporate Quality and customers with recalls or notifications to a regulatory body and other complaints. Maintain control over policies, SOPs, cGMP, ISO 9000/2000 and FDA/Regulatory requirements. Identify and periodically review training effectiveness. Responsible for housekeeping and safety awareness. Other duties as needed or assigned.

POSITION REQUIREMENTS: Experience in creating and implementing quality systems and cGMP validation protocols. Participation in internal, supplier, third party or FDA quality audits. Able to work in a cross-functional environment. Able to assess and recommend improvements to manufacturing environments. Strong knowledge of Quality Management Systems (21 CFR 820/210/211 & ISO 9000) and computer software. Ability to learn plastic injection molding, Nypro policies and SOPs. Good problem-solving abilities. Must be able to interact with customers and auditors in a professional manner both orally and in written communications. Computer software knowledge (Word, Excel, Lotus Notes, SPC, etc.), inspection, measuring and test equipment and blueprint reading are expected.

REPORTS TO: Quality Manager

SUPERVISES: n/a

EDUCATION: BS technical degree or equivalent of education and/or experience with emphasis on quality.

EXPERIENCE OR EQUIVALENT: 5 years experience in drug or medical device manufacturing environment.

Compensation commensurate with qualifications, a competitive benefits package and a commitment to your personal and professional development. Excellent compensation/benefit program includes: - 401K - profit sharing - medical/dental/life

Ref: 04080

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