Sr Quality Engineer

Location: Carlsbad, CA
Duration: prmanent position

Senior Quality Engineering Products and Systems

In this role, you have the opportunity to:

Our products include invasive and noninvasive hospital ventilators, patient interfaces, sensors, and monitoring equipment.   We believe that by understanding our customers’ problems we can ease the discomfort of ventilation by providing innovative solutions to improve the patient-ventilator experience, permit speech, and speed liberation. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device.

This position supports and guides a product development and sustain teams through the design life cycle, including the design transfer of the product into manufacturing, and incurring post market surveillance monitoring ensuring compliance with the Quality System Regulations, 21 CFR Part 820, and ISO 13485.  An associate in this position is viewed as an active and valued contributor to the design, risk analysis, project plan, process validation, and design transfer.   The associate would be required to balance business objectives and quality requirements to determine readiness of projects to proceed to the next phase.   Their background in risk management would enable them to conduct safety, efficacy and hazard analysis [SHA], and failure modes and effects analysis [FMEA].  Use those analysis to drive improvement in Quality Metrics such as product development cycle time.

You are responsible for:

  • Perform technical reviews and/or develop key documents including quality and reliability plans, FMECA, design reviews, design verification and validation plans/reports, product and process validation, pilot runs and sample size justification.
  • Approve Change Request end ensure their accuracy and adequacy
  • Develop inspection criteria for components and finished devices.
  • Perform and/or coordinate supplier audits as it pertains to R&D supplier selection process.  Including supplier part and process qualifications and validations.
  • Provide input to budget, planning, and evaluation processes.
  • Assist the Research and Development department to verify that; modifications to the manufacturing processes and/or product design do not affect product suitability for its intended use; assist in IQ, OQ, PQ of new equipment and processes.
  • Performs duties in compliance with relevant FDA QSRs and ISO regulations.

BEHAVIORS: The successful candidate will demonstrate:
Eagerness to Win
  • Take an outside perspective, serve our customers
  • Ensure speed of action and outpace competition
  • Ability to Take Ownership
  • Take Courageous Decisions
  • Has the ability to identify and solve a problem.
  • Focus on results over activity
  • Be Goal Oriented: Demonstrates high level ambition and positive attitude about long term prospects for successfully addressing new and demanding challenges.
  • Execute rigorously, see things through
  • Be Detail Mindedness: Apply the informed attention to facts and experiences that make one a highly competent, skilled expert
  • Ability to Team up and Excel
  • Have open and tough dialogues, productive conclusions
  • Collaborate
  • Learn, Improve, and Develop
  • Demonstrate Learning Agility: Aggressively learning and applying new skills/knowledge required to be successful within new, changing or uncertain conditions.

GROWTH and DEVELOPMENT: The successful candidate will:
Define with their manager goals for personal and professional development
  • Take accountability to execute their personal development plan to grow with in current role and to prepare for future roles.

You are a part of
Describe in two to three lines the place of the role in the organization and the team culture.
To succeed in this role, you should have the following skills and experience

EDUCATION:
B.S. degree in an engineering discipline, Electrical Engineer degree or a related technical field or equivalent is highly desirable. ASQ (CQE, CRE, CQA) Certifications a plus.

EXPERIENCE:
3+ years of experience as a Quality/Reliability Engineer, Design Engineer working within the framework of a Quality System. Experience with medical device manufacturing with electronic and/or electromechanical products preferred.

OTHER REQUIREMENTS:
Limited travel (0-5%).  Requires demonstrated proficiency in reading, basic math and use of office standard equipment – including computer.  Requires the ability to perform in a sedentary work environment (e.g. office) that may occasionally require lifting and carrying up to 15 pounds.

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