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Senior Quality Systems Engineer

  • Location

    Andover MA, United States

  • Sector:

    Quality & Validation

  • Job type:

    Permanent

  • Salary:

    $95,000 - $110,00

  • Contact:

    Callum Sparkes CLSUSA

  • Job ref:

    48865

  • Published:

    3 months ago

  • Expiry date:

    2020-10-17

Overview

Due to our rapid growth, we are looking for an experienced hands-on degreed Sr. Design Quality Engineer with at least 8 years of experience in Quality Engineering in the medical device industry (min. of 4 years in Design & Development). They need to have experience supporting the development of Class II or III disposable medical including capital equipment and embedded software systems and have a working knowledge and practical application of Design Controls and experience with 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62366, IEC 62304, IEC 60601-1 and MDD. They will support new product development teams as a core quality team member; provide input on customer needs, product requirements, participate in design reviews and lead and facilitate design verification & validation activities; author and/or execute design verification protocols and reports.
 

Essential Duties and Responsibilities Include:

  • Support new product development teams as core quality team member; provide input on customer needs, product requirements, participate in design reviews, etc.
  • Lead and facilitate design verification & validation activities; author and/or execute design verification protocols and reports.
  • Generate Quality plans for new products and work with R&D engineering to develop quality inspection plans for new components and sub-assemblies.
  • Lead and facilitate pre and post-market failure investigation and risk management activities.
  • Lead test method/equipment development and validation activities.
  • Maintain product technical files and Device History Files.
  • Identify process improvements related to design and development activities.
  • Support the quality management system, as required.

Experience:

  • BS in Engineering with at least 8 years of experience in Quality Engineering in the medical device industry (min. of 4 years in Design & Development). MS preferred.
  • Experience supporting the development of Class II or III disposable medical including capital equipment and embedded software systems.
  • Working knowledge and practical application of Design Controls and experience with 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62366, IEC 62304, IEC 60601-1 and MDD.
  • Experience writing and/or executing verification and validation protocols.
  • Practical knowledge and experience with statistical methods, including sample size justification using Minitab or other statistical software.
  • Process validation experience including IQ/OQ/PQ.
  • Ability to communicate ideas and information clearly, effectively and concisely.
  • Highly detail oriented with strong organization and prioritization skills.
  • Must possess a high level of energy with the ability to handle multiple projects and changing priorities.
  • Must be results-driven and exhibit a sense of urgency.
  • Six Sigma training/certification or CQE is a plus.
  • Some travel may be required (approximately 5 - 10%).