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Quality Engineer

Management Business Solutions
Lowell, MA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

SUMMARY: Management Business Solutions (MBS) is seeking a Quality Engineer for our biopharmaceutical client in Marlborough, MA. This individual will add value to the company as a quality resource to continuously improve quality methodology within the plant. Can work remotely 2 days a week.

 

RESPONSIBILITIES:

● Plans, supports and implements total quality programs.

● Works closely with Engineering and Manufacturing to design, specify, and install error-proofing systems and inspection methods.

● Fulfills the quality-related responsibilities of product/process launches.

● Formulates and assists in the formulation of work instructions and the development of product specifications.

● Serves as a liaison and coordinates activities of internal and external resources.

● Assists and/or leads internal and external contacts to resolve product and process problems.

● Investigates and solves manufacturing-related problems in assigned areas using formal problem-solving tools.

● Analyzes statistical data.

● Champions continuous improvement efforts.

● Researches, recommends, implements, and administers new and existing quality assurance processes.

 

QUALIFICATIONS:

● Bachelor’s degree in engineering.

● 5+ years previous quality engineer experience.

● Experience working in a Medical Device industry is required.

● Lead Quality Auditor certification is required and Quality Engineer (ASQ, CQE, CRE or equivalent) certification is preferred.

● Comprehensive knowledge of the rules and specifications regulating quality management systems, such as FDA 21 CFR 820, ISO 13485, etc.

● Good customer relations, strong analytical and problem-solving skills.

● Knowledgeable in Risk Management tools and requirements (i.e. - ISO 14971).

● Computer skills, including Windows, Outlook, Excel, PowerPoint, and statistical software programs.

 

MANAGEMENT BUSINESS SOLUTIONS IS AN EQUAL OPPORTUNITY EMPLOYER

Management Business Solutions

Address

Lowell, MA
USA

Industry

Manufacturing

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