Jobs · Quality Assurance · Massachusetts

Quality Engineer - Manufacturing

Fisher & Paykel Healthcare · Boston, MA · 1 wk ago
On-siteQuality AssuranceFull-time

About the role

You'll actively collaborate with Operations, Production, and Process Development teams. Your QMS and statistical knowledge will be key in providing training and guidance to uphold quality standards for both new and existing processes. Additionally, you will contribute to identifying and implementing improvements in our Quality Management System.

Responsibilities

  • Collaborate with Operations, Production, and Process Development teams.
  • Provide training and guidance to uphold quality standards for new and existing processes.
  • Contribute to identifying and implementing improvements in the Quality Management System.

Requirements

  • 3+ years of work experience in Quality Engineering in the medical device industry.
  • A tertiary qualification in Science or Engineering.
  • Working knowledge of standards and regulations (ISO13485, ISO14971, 21 CFR Part 820, MDR).
  • Experience with process and test method validation activities.
  • Working knowledge of statistics and process improvement tools.
  • Six Sigma or CQE certification is preferable.

Qualifications

  • Excellent communication skills both written and verbal with the ability to share complex ideas, positively influence, negotiate, and challenge with tact and diplomacy.
  • Strong problem-solving ability, (both through your own independent thinking and collaboration across the business) and a strong resilience when navigating problems.
  • An ability to build relationships at all levels within the organization.

Skills

  • Practical attitude.
  • Willingness to collaborate.
  • Proactive nature.
  • Results-focused approach.

Benefits

  • Employee share purchase scheme.
  • Discretionary Bi-annual Profit share.
  • Generous Paid Parental Leave.
  • Life, Critical illness and Income Protection Insurance & discounted Health Insurance.
  • Performance based annual Salary Reviews.
  • Active Social clubs & community groups.
  • In-house training programs from external providers.
  • School holiday programme subsidy.
  • Free Parking, beautiful campus with green spaces & subsidised Café’s.
  • Access to state-of-the-art facilities.

Pay

Details TBD.

Schedule

Full-time.

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