Primary Talent Partners has a full-time, 13-month contract Principal Quality Engineer opening with a Fortune 500 Medical Device client located in Billerica, MA. Pay range for this position is $60 to $70 per hour based on overall experience.

Overview:

We are seeking a highly skilled and experienced Principal Quality Engineer to join our Medical Device client's team. The ideal candidate will have 7 years of experience in quality assurance within a manufacturing environment, with a strong background in process validation and computer software validation. If you are results-oriented, possess excellent problem-solving skills, and thrive in a fast-paced environment, we encourage you to apply.

Key Skills:

1. Statistical Techniques for Data Analysis
2. Design of Experiments / Process Characterization
3. Validation Experience (IQ, OQ, TMV, PQ)
4. CAPA (Corrective Action / Preventive Action)
5. Familiarity with Minitab Statistical Software

Nice-to-Have Skills:

1. Bachelor's Degree in Mechanical or Electrical Engineering
2. Ability to build custom fixtures
3. Proficiency in reading drawings, BOMs, GD&T
4. Experience in mechanical assembly and components
5. Ability to work with vendors on dimensions and order components
6. Equipment qualification experience in medical device manufacturing assembly line
7. Experience working in a cleanroom environment in a medical device company

Responsibilities:

1. Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.
2. Collaborate with engineering and manufacturing functions to ensure quality standards are met throughout the production process.
3. Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
4. Design or specify inspection and testing mechanisms and equipment.
5. Conduct quality assurance tests and perform statistical analysis to assess product precision and accuracy.
6. Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
7. May specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, or research and development as they apply to product or process quality.

Requirements:

• Bachelor's Degree in Mechanical or Electrical Engineering preferred.
• Minimum of 7 years of relevant experience in a manufacturing environment.
• Proficiency in statistical techniques for data analysis.
• Experience with design of experiments and process characterization.
• Strong validation experience, including IQ, OQ, TMV, and PQ.
• Previous experience with CAPA processes.
• Familiarity with Minitab Statistical Software.
• Excellent problem-solving skills and attention to detail.
• Ability to work collaboratively in a team environment.
• Strong communication and interpersonal skills.

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
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