Sr. Quality Engineer

Primary Talent Partners has a 12 month contract opening for a Sr. Quality Engineer to join a multinational medical device company for an onsite position in Louisville, CO. 

Pay: $50.00/hr - $60.00/hr based on experience 
Contract: W-2, 12 months, extensions likely, conversion possible, cannot support C2C or provide sponsorship

Summary:
The Primary function of this position is to support Operations Quality while the site is working on a New Product Launch of Capital Equipment.  In this role, you will review and approve validations (process, software, equipment)  You will work hand in hand with Manufacturing Engineering to develop Operator Work Instructions and set up assembly stations. You will work directly with Inspection to help establish inspection methods of incoming components and assist in resolving inspection issues.  In addition, this person will assume ownership of any NCMR or CAPA that is created from Operations Quality.

,Additional Responsibilities:

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• 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.

Required Qualifications:

• Completed Bachelor's degree in Engineering or Science related field is required. 
• 5 years of applicable experience is required. 
• Experience with Medical Device Manufacturing is required. 
• Experience with owning and processing NCMRs and CAPA. 
• Experience with reviewingequipment and software Validations.
  

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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