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Quality Assurance Validation Specialist
2 months ago
About UFP Technologies:
UFP Technologies is a leading designer and custom manufacturer specializing in comprehensive solutions for medical devices, sterile packaging, and other highly engineered products. As a crucial component in the medical device supply chain, UFP serves as a trusted outsourcing partner for many of the world's top medical device manufacturers. Our single-use and single-patient devices and components are integral to a variety of medical applications, including minimally invasive surgery, infection control, wound care, wearable technology, orthopedic soft goods, and implants.
Benefits:
- Comprehensive Medical, Dental, Vision, Life, and Disability Insurance
- 401K Plan with Employer Matching
- Generous Paid Time Off, Holidays, and Employee Discounts
Position Summary:
The Validation Engineer will take the lead in validation initiatives for new products and processes. This role involves independent work with medical clients or collaboration within cross-functional teams to design and implement validation protocols. The Validation Engineer will partner with project engineers, program managers, and quality and production teams to develop processes that meet customer specifications while achieving target production rates and material yields.
Key Responsibilities:
- Collaborate with medical clients, guided by program management and design engineers, to establish quality requirements and validation protocols (IQ, OQ, PQ, PPAP).
- Perform statistical analyses to support process validations.
- Provide hands-on design assistance using tools such as SolidWorks, CAD, and statistical software to create new products that fulfill customer needs.
- Act as the technical point of contact as necessary, overseeing projects from development through to production validation.
- Educate staff on operational parameters to ensure quality product output.
- Engage in individual assignments and cross-functional team efforts to develop, enhance, and launch medical products and manufacturing processes.
- Draft work instructions and inspection documentation.
- Compose clear technical reports regarding both existing and newly developed processes.
- Train operators and quality personnel on work instructions and inspection methods.
- Manage projects effectively to meet or exceed timelines and budget constraints.
- Identify and escalate issues as needed, proposing solutions to align with customer requirements and business profitability objectives.
- Execute additional duties as assigned.
Qualifications:
- Bachelor's degree in Engineering or a related technical field (e.g., polymer science, material science, chemistry) with 3-5 years of relevant experience in medical packaging, supply chain, or device design.
- A minimum of three years' experience in product validation.
- Strong statistical background, proficient in Minitab SixPack for process validations.
- Familiarity with change control processes.
- Knowledge of thermoplastics, foamed plastics, and manufacturing processes relevant to medical packaging.
- Understanding of sterilization protocols for medical packaging.
- Solid project management capabilities, including the ability to handle multiple projects concurrently and identify critical paths.
- Familiarity with medical device qualification standards and quality management systems such as ISO 13485, ISO 17664, and 21 CFR 820 regulations.
- Hands-on experience in developing quality requirements and validation protocols with medical clients.
- Experience in writing work instructions and inspection documentation.
- Able to instruct operators and quality personnel on procedures.
- Proficient in writing clear technical reports on processes.
- Project management experience with a track record of meeting deadlines.
- Strong understanding of manufacturing processes and effective communication on the production floor.
- Comfortable addressing issues and suggesting solutions to meet customer and business goals.
- Willingness to travel up to 15% as required.
- Excellent verbal and written communication skills.
- Strong teamwork abilities.
UFP Technologies, Inc. is an Equal Opportunity/Affirmative Action employer. We welcome applications from individuals of all backgrounds, including minorities, women, veterans, and individuals with disabilities.
