Sign in

Senior Quality Engineer - RT

Company:
Absolute Opportunities
Location:
Carlsbad, California, 92008, United States
Posted:
October 12, 2018

Description:

Senior Quality Engineer - RT

Carlsbad, California 92008

Job Description

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.

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.

Required Knowledge, Skills, and Abilities: (Submission Summary)

1. B.S. degree in an engineering discipline, Electrical Engineer degree or a related technical field or equivalent is highly desirable.

2. ASQ (CQE, CRE, CQA) Certifications a plus

3. 3+ years of experience as a Quality/Reliability Engineer, Design Engineer working within the framework of a Quality System

4. Experience with medical device manufacturing with electronic and/or electromechanical products preferred

5. 5+ to 7 years experience

6. Salary Expectation?

7. Must be a US Citizen or Green Card holder?

8. Current Address?