job summary: JOB DESCRIPTION
This position supports and guides a product development team through the design life cycle and transfer of the product into manufacturing, 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. Demonstrate Learning Agility: Aggressively learning and applying new skills/knowledge required to be successful within new, changing or uncertain conditions.
location: Carlsbad, California
job type: Contract
salary: $60 - 70 per hour
work hours: 8 to 5
responsibilities: OUTCOMES: The successful candidate will:
- 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 Minded: 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
- Learn, Improve, and Develop
- 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.
- 5-8 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.
- 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.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.