Quality Engineer

3 days ago

Franklin, Massachusetts, United States GCX Healthcare Solutions Full time

CAREERS AT GCX

GCX has been a provider of medical instruments and IT mounting solutions for the healthcare industry since 1971. A dedication to the healthcare industry has allowed our teams to develop a unique understanding of the interaction between medical devices, users, and healthcare environments. In collaboration with our partners and customers, we create products that are utilized in virtually all healthcare settings to provide secure positioning, mobility, and ergonomic access to medical devices and computer hardware. Overall, we are committed to developing tools and solutions to enable caregivers to deliver improved patient care.

POSITION SUMMARY:

This is a temporary 6-month Quality Engineer position with potential to become permanent based on business needs and individual performance. In this role, the Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve the capability of processes.

KEY RESPONSABILITIES:

  • Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
  • Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques, and/or other improvement tools and programs.
  • Conduct benchmarking to develop more effective methods for improving quality.
  • Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions and product life cycle management.
  • Supports activities related to the Material Review Board.
  • Conduct investigation, bounding, documentation, review, and approval of non-conformances, CAPAs, and customer complaints. Escalation of quality issues as appropriate.
  • Accountability and ownership for material identification, material segregation, classification of defect types, including the successful application of these techniques on a day-to-day basis in manufacturing.
  • Analyze/review the effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
  • Accountability and ownership of Quality metrics, including maintenance and review of leading and lagging indicators of quality.
  • Develop, interpret, and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
  • Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
  • Develop, interpret, and implement standard and non-standard sampling plans.
  • Assess the effectiveness of measurement tools, destructive tests, non-destructive tests, and measurement system analysis.
  • Travel requirements: 25% including international travel.

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor's degree (B.S.) in an Engineering, Technical, or Scientific field
  • Minimum of 6 years of relevant experience, or an advanced degree with a minimum of 4 years of relevant experience
  • Understanding of the NPI (New Product Introduction)/Design Controls process and Process Validation expertise is preferred.
  • A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
  • Prior experience working in the medical device industry is preferred.
  • CQE or LSSGB certification preferred.
  • Project Management skills preferred.
  • Commitment to excellence and high standards
  • Excellent written and oral communication skills preferred.
  • Strong organizational, problem-solving, and analytical skills
  • Ability to manage priorities and workflow.
  • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
  • Acute attention to detail
  • Demonstrated ability to plan and organize projects.
  • Ability to work independently and as a member of various teams.
  • Proven ability to manage multiple projects and meet deadlines.
  • Ability to develop clear, concise, and timely oral and written reports.
  • Accurately complete detailed forms and reports.

ADDITIONAL DETAILS:

  • Type: Full-Time, Temporary
  • Location: Franklin, MA (On-site)
  • Salary: 115, ,000 Annualized Base Pay
  • Duration: Six months, with potential for extension or permanent hire based on performance and business needs

EQUAL OPPORTUNITY

GCX values and employs unique individuals of different ages, genders, ethnicities, physical and mental abilities, and lifestyles. We do not discriminate (or tolerate discrimination by our employees) against any applicant or employee based on age, gender, race, color, religion, national origin, disability, marital status, veteran status, sexual orientation, or any other characteristic protected under law.

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