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Job: Senior Quality Engineer (Device/Combo Products) – Top $$, Frankel Staffing Partners, RTP, NC
Senior Quality Engineer (Device/Combo Products) – Top $$
RTP, NC 27709 United States
Our client, an RTP-based company that is developing a growing portfolio of combination products in the dermatological space, is actively recruiting for a highly knowledgeable, focused, motivated and can-do Quality Engineer to assume key role on its top-notch team.
Key things to note:
• This is a hybrid role contributing to both product design/development and process development Quality efforts. Seek candidate with exposure to both. Design History Files, Validation, Process Transfer all required
• These are combination products – primarily semi-solid products that are delivered using pumps, tubes, etc. Experience with combination products or medical devices will be important
• This is an emerging company in which strategies, policies and practices are still being developed. This Engineer will be instrumental in creating the blueprint that others will follow
The focus of the role will be the implementation and maintenance of the company’s design control systems for combination products as well as performing product, process and equipment validations/qualification, medical device design and development document writing and review. Seek highly versatile candidate who enjoys a broad-based and challenging role.
Specific responsibilities will include:
• Act as Quality Representative and primary reviewer on design and development projects
• Lead and support design control activities including User-, Design-, and Process- FMEAS in order to proactively identify and mitigate risks through appropriate control strategies and risk mitigation plans
• Oversee and provide technical input for method development, qualification [measurement system analysis (MSA's)], as well as method transfer for all critical performance test methods
• Participate in design reviews and provide expert Quality/technical input to ensure potential problems are identified and corrected early in development to minimize negative impact
• Own the Change Control Program, providing technical expertise as well as partnering with other functions to assure timely and effective change management.
• Work closely with Process Engineers to develop, perform, review and approve process, test method and equipment validation/qualifications, including software and automation/controls
• Perform product and process evaluations to identify areas for improvement
o Recommend solutions to identified problems
o Implement approved changes using sound quality engineering principles
o Fully document requirements
• Develop, deploy and execute validation programs and procedures, including scheduling and maintaining the requalification and periodic review program
• Review product and process changes for effect on existing validations, recommend and perform revalidations
• Provide supervision for contract validation resources as needed
Ideal candidate will offer a related degree and 6+ years handling similarly challenging work in a combination product, medical device or directly-related setting. Combination product exposure strongly preferred.
Other priorities include:
• In-depth knowledge of 21 CFR P Part 4, Part 11, Parts 210/211, Part 820
• Expertise in quality systems, validation principles, Computer Systems and engineering design fundamentals
• Familiarity with Design History Files
• Strong statistical skill sets (i.e., Minitab, SAS, etc.)
• Certified Quality Engineer (CQE) preferred Certified Six Sigma Green/Black Belt or equivalent preferred
• Familiarity with “lean” manufacturing principles and the use of appropriate Quality principles.
• Longevity and impact in previous positions
Finally and critically, we seek a hands-on, get-things-done leader. This is a dynamic, empowered, collaborative and mission-driven setting. We seek a highly skilled overachiever who will thrive
This is an immediate need and a critical need. Client will pay top dollar to attract and retain a star.
Please forward Word resume for prompt consideration. Local candidates only.
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.
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