Provides quality engineering technical support to the entire business related to corrective actions, process control, statistical analysis, customer complaints, component validation, product measurement and testing, product launch, product certification, and audits.
Essential Duties and Responsibilities:
Investigates customer returns and complaints and provides corrective action / customer problem resolution onsite and at customer facilities.
Implements corrective action measures to prevent re-occurrence.
Performs product validation preparation and presentation of medical components and/or products.
Supports development of protocols for IQ, OQ, PQ.
Provides product metrology and measurement.
Provides frequent instruction, guidance, and direction for manufacturing, engineering, materials, customers, and suppliers in performance measurement.
Provides program launch support onsite and at customer facilities.
Performs preventive action and continuous improvement.
Manages material containment onsite and at customer facilities.
Performs internal system and process audits.
Performs SPC and capability analysis.
Supports manufacturing and engineering problem solving efforts on in-process and vendor related quality problems.
Supports product development and production transfer to ensure process capability exists and product requirements are understood.
Participates in and conducts supplier audits.
Writes procedures, work instructions and creates quality system forms.
Improves and monitors inspection processes.
Installs statistical sampling processes.
Issues corrective action reports.
Associates degree or equivalent in quality, operations management, or engineering related fields, plus a minimum 5 years of quality experience in manufacturing environment or Bachelors degree with 2 years of experience in a manufacturing environment.
Experience in ISO quality system procedure requirements.
Quality Engineer (CQE) certification and/or training a plus.
UFP Technologies, Inc. is an Equal Opportunity/Affirmative Action employer Minorities/Women/Veterans/Disabled.
UFP Technologies is a producer of innovative, custom-engineered components, products, and specialty packaging for a wide range of industries including Medical, Aerospace, Defense, Automotive, Consumer, and Electronics. UFP’s highly engineered and inventive developments are the result of our culture of innovation and a key reason we have doubled in size over the past decade. Our customer base conti...nues to expand at a rapid pace and now is the ideal time to join our dynamic and fast paced environment.
Our mission is to provide a professional, energetic, and family oriented work experience. Since 1963, our reputation for providing high quality services with integrity has earned us the trust of our customers and our employees. If you are ready for a career with a forward-looking organization that fosters professional development and career advancement, you're ready for UFP Technologies.