Quality Assurance Validation Specialist
1 week ago
About UFP MedTech:
UFP Technologies specializes in designing and manufacturing tailored solutions for medical devices, sterile packaging, and other highly engineered products. As a crucial player in the medical device supply chain, UFP serves as a trusted outsourcing partner for leading medical device manufacturers globally. The company's single-use and single-patient devices and components are integral to various medical applications, including minimally invasive surgery, infection control, wound management, 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 is responsible for spearheading validation initiatives for new products and processes. This role involves working independently with medical clients or as part of cross-functional teams to formulate and implement validation protocols. Collaborating with project engineers, program managers, quality assurance, and production teams is essential to create processes that meet customer specifications while achieving optimal 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).
- Conduct statistical analyses to support process validations.
- Provide hands-on design assistance using tools such as SolidWorks, CAD, and statistical software to develop new products that align with customer needs.
- Act as the technical point of contact as necessary, overseeing projects from development through production transfer, including validation.
- Educate team members on operational parameters to ensure quality product output.
- Engage in individual tasks and collaborate with cross-functional teams 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 protocols.
- Manage projects to meet or exceed timelines and budget constraints.
- Identify and escalate issues as needed, proposing solutions to fulfill customer requirements and business profitability objectives.
- Perform 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.
- At least three years of experience in product validation.
- Strong statistical background, proficient in Minitab SixPack for process validations.
- Familiarity with change control processes and management.
- Knowledge of thermoplastics, foamed plastics, and manufacturing processes used in medical packaging.
- Understanding of sterilization requirements for medical packaging.
- Solid project management capabilities, including the ability to manage multiple projects, identify critical paths, and navigate new product introduction (NPI) processes.
- 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 collaborating with medical clients to develop quality requirements and validation protocols (IQ, OQ, PQ, PPAP).
- Experience in drafting work instructions and inspection documentation.
- Able to instruct operators and quality personnel on work instructions and inspection procedures.
- Proficient in writing clear technical reports on existing and newly developed processes.
- Demonstrated project management experience with a track record of meeting deadlines.
- Strong understanding of manufacturing processes, with the ability to communicate effectively on the production floor.
- Comfortable addressing issues and proposing solutions to meet customer expectations and business goals.
- Willingness to travel occasionally (
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