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Quality Engineer
2 months ago
About UFP MedTech:
UFP Technologies is a designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. UFP is an important link in the medical device supply chain and a valued outsource partner to most of the top medical device manufacturers in the world. The Company’s single-use and single-patient devices and components are used in a wide range of medical devices and packaging for minimally invasive surgery, infection prevention, wound care, wearables, orthopedic soft goods, and orthopedic implants.
UFP Technologies, Inc. offers a competitive benefits package, including but not limited to:
- Medical, Dental, Vision, Life, Disability Insurance
- 401K with a matching contribution
- Paid time off, Paid holidays, Employee discounts and much more
Location: This position is based on-site in Chicopee, MA. The position holder will need to be within commuting distance (within 45 min). The position will be on-site full time.
Qualified applicants must be eligible to work in the United States to be considered for this opportunity. Employment based visa sponsorship (including H01B sponsorship) is not available for this position.
Quality Engineer Summary:The Quality Engineer has the responsibility for the development and implementation of quality systems for sealed plastic film products in an ISO 13485 environment involving multiple industries.
Quality Engineer Essential Duties and Responsibilities:- Provides oversight and approval of IQ, OQ, PQ validation protocols, execution and reports on new and sustaining products.
- Oversees PPAP activities and produce PPAP submittal packages on new and sustaining products.
- Participates as a member of the FMEA team related to primarily new and developing products.
- Develops and documents control plans.
- Conducts statistical capability studies and sets up SPC control charts.
- Documents inspection procedures and test methods.
- Performs regular audits of processes and materials to ensure that: Inspections, tests, and operations are being conducted and documented according to applicable specifications and standard operating procedures. Assures the results of inspections and tests are in compliance with all applicable requirements.
- Monitors final release of finished product based on above audits.
- Monitors and interprets SPC charts to assure that processes remain in control.
- Directly interfaces with production in the operator training process for quality issues.
- Reviews reject reports and initiate corrective action as required.
- Directly interfaces with other support departments as required.
- Completes special testing when required for failure analysis, validations, etc.
- Sets up inspection/test equipment.
- Observes all safety regulations and procedures.
- Follows all department and company policies and procedures.
- 4 year college degree in related field.
- Experienced in IQ, OQ, PQ validations.
- Good working knowledge of ISO 13485, PPAP, FMEA, AIAG Control Plan Methodology, and SPC.
- ASQC Certified Quality Engineer preferred.
- Good computer skills.
- Ability to interact with all levels of the organization and with suppliers.
- Strong written and oral communication skills.
- Strong analytical skills in problem analysis and problem solving.
To apply for this job please create a profile with us through our online application system. Click the "Apply" box in the upper right-hand corner to start the application process. Or, if you already have a social media account with LinkedIn, Google, or Facebook you can use your log in credentials to apply.
For more information on UFP MedTech, visit www.ufpmedtech.com.
UFP Technologies, Inc. is an Equal Opportunity/Affirmative Action employer Minorities/Women/Veterans/Disabled.
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