Primary Talent Partners has a full-time, 13-month contract Sr. Quality Engineer opening with a Fortune 500 Medical Device client located in Billerica, MA. Pay range for this position is $45 to $55 per hour based on overall experience.

Overview:

We are seeking a highly skilled and experienced Sr. Quality Engineer to join our Medical Device client's team. The ideal candidate will have 2-5 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. Validation Knowledge
2. Self-Driven
3. Manufacturing Experience

Responsibilities:

1. Work closely with the engineering team to execute validation processes.
2. Update process Failure Mode and Effects Analysis (pFMEA) documentation.
3. Update and maintain quality procedures.
4. Identify and troubleshoot process inefficiencies to drive continuous improvement initiatives.

Products Supported: The role will support both disposable products, particularly Sphere 9, and capital equipment.

Job Description:

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.
• Collaborate with engineering and manufacturing functions to ensure quality standards are met throughout the production process.
• Design or specify inspection and testing mechanisms and equipment.
• Conduct quality assurance tests and perform statistical analysis to assess product precision and accuracy.
• Ensure corrective measures meet reliability standards and that documentation is compliant with requirements.
• May specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, or research and development.
• Act as an individual contributor with responsibility in a professional discipline or specialty.
• Deliver and/or manage projects assigned, working with other stakeholders to achieve desired results.
• Provide guidance, coaching, and training to other employees within the job area.
• Typically manage major or moderately complex projects, involving delegation of work and review of work products.

Requirements:

• Bachelor's Degree in Engineering or related field.
• 2-5 years of experience in quality assurance, preferably in a manufacturing setting.
• Strong knowledge of process validation and computer software validation.
• Experience with process characterization, test method validation, and equipment qualification.
• Results-oriented with the ability to use data, KPIs/Metrics, and tools/systems like MOS, CAP, and Lean Sigma.
• Excellent problem-solving skills and ability to drive process improvements.
• 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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