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Quality Engineer

Company: Phillips-Medisize
Location: Clinton
Posted on: January 15, 2022

Job Description:

Phillips-Medisize, a Molex Company is an end-to-end provider of innovation, development and manufacturing solutions to the pharmaceutical, diagnostics and medical device industries. Our Clinton, MA location is seeking a Quality Engineer to support manufacturing of injection molded parts and assembly.
What You Will Do In Your Role

  • Responsible for QMS deliverables, including but not limited to: customer complaints, risk analysis, failure mode and effects analysis, CAPA, and process/equipment verification/validation
  • Leads investigation of out of specification situations to determine if there is impact to released product. Write technical reports in support of NCMR investigations, CAPAs and containment activities
  • Uses quality tools to assess performance data, solve manufacturing quality problems and support validation strategies, including: process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques
  • Monitors production processes and products for adherence to company and regulatory standards and practices. Participates in quality improvement initiatives and projects
  • Initiates, reviews and approves change requests and deviations
  • Manage the qualification of processes performed by suppliers; troubleshoot and lead corrective actions relating to supplier performance
  • Interfaces with engineering, operations, customer, and vendor representatives to ensure all requirements are met
  • Communicate and coordinate activities and deliverables between the customer and manufacturing facility
  • Assist with second- and third-party quality audits as needed
    The Experience You Will BringRequirements:
    • Two (2) years or more Quality Engineering experience in a regulated industry
      What Will Put You Ahead
      • Experience and working knowledge of FDA Quality System Regulations and ISO 13485.
      • Bachelor's degree
      • Experience with SAP or other ERP system
      • Experience with Minitab
      • Experience writing technical and/or validation reports
      • Experience leading CAPA or complaint investigations
        Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter.
        At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.
        Equal Opportunity Employer, including disability and protected veteran status.Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please visit the following website for additional information: www.kochcareers.com/doc/Everify.pdf

Keywords: Phillips-Medisize, Worcester , Quality Engineer, Engineering , Clinton, Massachusetts

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