6 days old

Quality Assurance Engineer

Westborough, MA 01581

Help us improve access to life-changing therapies that can transform human health

We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.

Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.

What you'll do

Responsible for providing Quality Management system support within manufacturing and engineering operations in accordance with documented procedures and practices. This is a key technical role responsible for supporting the development, implementation and continuous improvement of established Quality Assurance processes. The role involves active participation as a Quality Assurance representative within New Product Introduction, Design Transfer activities and manufacturing/distribution changes.

  • Acts as QA Lead representative within appointed business projects.
  • Supports the development, implementation, and continuous improvement of process effectiveness and efficiency at the site
  • Ensures project & process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of detailed process flow diagrams that describe critical process
  • Act as QA approver of QMS records/reports within projects
  • Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc.
  • Leads Root Cause Analysis of nonconformance incidents, including the documentation of completed investigations, CAPA plans and support to Quality letters.
  • Supports the QMS Internal Audit program
  • Identifies and reports any EHS, Quality or Compliance concerns and takes immediate corrective action or escalation as required
  • Aware of and complies with the company Quality Management System, Quality Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
  • Completes all planned EHS and Quality & Compliance training within the defined timelines
  • Identifies and reports any EHS and quality or compliance concerns taking immediate corrective action as required.

    Who you are

    • Bachelor€™s degree in engineering or health sciences field; or a High School diploma/GED and minimum 6 years work experience in a Quality or Regulatory Assurance related field
    • Minimum 5 years€™ experience in an ISO 9001, medical device or pharmaceutical industry in an Engineering, Quality or Regulatory related role
    • Experienced in Customer complaint handling including leading RCA & CAPA plans
    • Demonstrated understanding of product development lifecycles, design change, document change control, process verification and validation methodologies, manufacturing/production process control methodologies, and servicing in a medical device environment.
    • Basic understanding of materials, properties, manufacturing processes, and product assembly.
    • Experience with cGMP and governmental regulations related to drug manufacturing
    • Ability to read and interpret professional journals and technical procedures.
    • Strong communication and writing skills
    • Proficient with Microsoft tools; Word, Excel, Power Point, Project and Visio.

      Additional Eligibility Requirement
      Cytiva will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

      Desired Characteristics

      • Advanced Engineering/Scientific or Regulatory Affairs degree
      • Product-specific knowledge in biomanufacturing or Single Use Systems
      • Demonstrated program management or leadership skills
      • Direct experience with cGMP and/or ISO 13485
      • Demonstrated experience prioritizing conflicting demands in a fast-paced environment
      • Demonstrated strong time management skills
      • Ability to work independently and in a team setting
      • Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English (and where appropriate, be able to communicate in the local language verbally and in writing).
      • Excellent interpersonal, organizational, and influencing skills
      • Ability to analyse and process data, and draw the appropriate conclusions
      • Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
      • Exceptional analytical, problem solving & root-cause analysis skills with experience of working with continuous improvement tools: (e.g. DMIAC, SPC, Lean SS, 5S)
      • Experience leading and implementing change
      • Experience performing internal audits and participating in external audits
      • Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.

        Who we are

        Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you€™ll feel right at home here. If you€™re flexible, curious and relentless, you€™ll belong. If you are excited about a global culture, this can be the place to further your career.

        Want to know more? Take a look at our Instagram, Twitter and LinkedIn pages!

        Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.

        As part of the Danaher family of companies, our work at Cytiva is supported by a global science and technology innovator. In addition to Danaher€™s unrivaled leadership training and professional development programs, our relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life€™s Potential.

        Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The €œEEO is the Law€ poster is available here.","industry":"Biotechnology


Posted: 2020-05-21 Expires: 2020-06-20

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Quality Assurance Engineer

Westborough, MA 01581

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