15 days old
2018-08-022018-08-31

Design Quality Engineer IV

Jabil Inc.
Clinton, MA
  • Job Code
    214519

About Our Company



NP Medical Inc., a subsidiary of Nypro, a Jabil company, is an innovator and supplier of medical devices that address the large-scale needs of the infusion therapy and vascular access markets. The goal that motivates us every day is to provide compelling product solutions that make quality patient care possible by improving patient outcomes and caregiver safety at an affordable cost. It is a deep understanding of the consequence of our work that has fueled NP Medicals product innovation, guided our daily operations, and defined our customer and caregiver engagement for over thirty years. This rich tradition has produced an enduring and winning culture marked by excellence, compassion, and collaboration that extends to our customers, caregivers, and patients alike.





Position Summary



Candidate will serve as the Quality team lead within cross-functional teams in the development of NP Medical products. Provide Quality Engineering support throughout the development process in order to ensure high quality product, including the use of statistical techniques to assist in the execution of design verification and validation. Responsible for establishing and achieving design goals for quality, customer needs, business timelines, and manufacturability. Utilize quality engineering methodologies and practices which meet NP Medical, customer and regulatory requirements.





Key Responsibilities



  • Provide Design Quality Engineering support to cross-functional development teams for NP Medical Inc. products.

  • Participate in project teams to review and develop clear and concise user requirements, product specifications, plans, usability studies, design verification and validation studies, risk management file and other relevant design control deliverables.

  • Lead test method validation for design verification and validation.

  • Summarize results of experiments by creating tables, charts and reports.

  • Must be able to interpret data and convey results; create statistical models; calculate sample sizes/sample plans for testing research hypotheses; and conduct data analyses to support ongoing projects.

  • Demonstrate mastery and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards.

  • Support FDA 21CFR820/EU MDD/MDR, ISO13485 requirements by creating and reviewing design control deliverables and requirements.

  • Articulate quality initiatives and considerations with internal and external customers and champion quality initiatives within project teams.

  • Lead/Support biocompatibility activities.

  • Provide Regulatory guidance to ensure device is correctly classified and conforms to relevant regulations, standards and guidances.

  • Act as ISO 14971:2012 Champion and leads in the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).

  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

  • Lead Root Cause investigations, corrective action determinations, and verification of effectiveness (CAPA) using proven quality tools and methodologies.

  • Support regulatory submissions.

  • Serve as Subject Matter Expert for the Design Control System during audit activities.

  • Establish and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).

  • Lead the design and analysis of inspection and testing methods.

  • Assist with managing Part Files that define statistical analysis requirements and any associated control limits.

  • Audit quality systems for deficiency identification and correction.

  • May provide direction and mentoring to junior QA Engineers.

  • Demonstrate competence in Quality Engineering body of knowledge.

  • Assist in the selection of appropriate analytical procedures.

  • Write, review, approve design verifications/ validations in accordance with industry expectations.

  • Support Quality System software validation as needed.

  • Support all company safety and quality programs and initiatives.

  • May perform other Quality related duties and responsibilities as assigned.

Requirements:



  • BS degree or equivalent, Masters preferred

  • 10+ years of experience within the Medical Device Industry or an equivalent combination of education, training or experience.

  • Deep understanding of Quality Systems Regulations (QSR 21 CFR Part 820), MDD/MDR, ISO13485 is required.

  • ASQ and/or DFSS certification strongly desired.

  • Deep understanding of Risk Management, Product Life Cycle, UDI, PDP process, EU market release and packaging.

  • Familiar with injection molding and molding defects.

Skills:




  • Statistics / Analytics expertise a must

  • 21CFR820

  • MDD 93/42/EEC /MDR 2017/745

  • ISO 13485:2016

  • ISO 14971-2012

  • ISO 10993

  • ASQ Certification preferred

  • Strong teamwork skills mandatory
  • MINITAB

  • MathCad

  • Test method validation / Gage R&R

  • Excellent written and verbal communication skills required.

  • Microsoft Office products (Excel, Word and PowerPoint)





Jabil is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other status protected by law.







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Design Quality Engineer IV

Jabil Inc.
Clinton, MA

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