Sr Quality Engineer – Medical Device

Grove Technical Resources, INC; Danvers (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A staffing agency is seeking a Sr Quality Engineer for a medical device role in Danvers, Massachusetts. The ideal candidate will have strong experience in quality engineering and risk management, ensuring compliance with industry standards. This fully onsite position requires a bachelor's degree in engineering and relevant experience. Competitive contract available.

Qualifications

• 4 years of work experience in Engineering and/or Quality with Bachelor's Degree.
• 2 years of work experience in Engineering and/or Quality with Advanced Degree.
• Demonstrated knowledge of process validation and risk management.

Responsibilities

• Provide Quality Engineering support for commercial medical device products.
• Develop and maintain quality standards for products.
• Collaborate with functions to ensure quality standards.
• Conduct quality assurance tests and statistical analysis.
• Present technical data to internal and external groups.

Skills

Medical Device Design & Development

Risk Management

Statistical analysis

Technical Writing

FMEA

Education

Bachelor’s Degree in Engineering, Science, or technical field

Advanced Degree in Engineering, Science, or technical field

Tools

SAP QM

SPC Software

Job description

Overview

Job Title: Sr Quality Engineer – Medical Device

Job Location: Danvers, Massachusetts (Fully Onsite)

Type: W2 Contract

Duration: 6 Months

Job Description: Technical skills that are required for the role include Medical Device Design & Development; Risk Management: dFMEA, pFMEA, Statistical analysis; Technical Writing: IQs, PQs, TMVs; and 5 years of experience.

Responsibilities

• Provide Quality Engineering support for commercial medical device products.
• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished materials products.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.
• Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
• Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements.
• Present technical data to groups within and outside the organization.
• Utilize quality tools to include Risk analysis, FMEA, statistical techniques including six-sigma and DOE (design of experiments), root cause analysis, reading and correcting drawings.

Qualifications

• Must Have: Minimum Qualifications
  • Bachelor’s Degree in Engineering, Science, or technical field AND 4 years of work experience in Engineering and/or Quality OR
  • Advanced Degree in Engineering, Science, or technical field AND 2 years of work experience in Engineering and/or Quality
• Nice to Have: Preferred Qualifications
  • SAP QM or SPC Software Experience
  • Effective verbal and written communication, analytical, influencing, and interpersonal skills
  • Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016
  • Demonstrated working knowledge of process validation, statistical methods, and risk management.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Engineering, Design, and Manufacturing

Industries

• Medical Practices, Medical Equipment Manufacturing, and Software Development