Quality Assurance Engineer
Quality Assurance Engineer
Posted on :
26-04-2025
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1 Vacancy
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Job Description
Description
The Quality Assurance Engineer will support the development and maintenance of ASP products and the quality system.
Responsibilities:
- Provide expertise and experience with general manufacturing processes for Medical Device Capital Equipment or Medical Devices
- Knowledgeable of nonconformance systems and of the requirements for first article inspection incoming in process inspections and lot release testing including sampling strategies and test methods
- Provide expertise on FDA Quality Systems regulations and ISO 13485
- Proficient in the understanding of regulatory requirements for medical devices and will demonstrate proficiency with statistical methods sampling design of experiments process capability analysis FMEA and FTA hazard analysis
- Experience using Six Sigma methodology be able to perform process variability studies risk analysis and test method variability will review and approve validation and qualification protocols and support the of process / product qualifications & validations (IQ OQ PQ)
- Provide support to develop and maintain documentation to support the validation process specifications manufacturing and test procedure and will participate and collaborate with supply chain R&D engineering operations engineering and manufacturing to identify potential areas of process variability address root causes and implement improvements
- Possess leadership skills and will have a strong electrical engineering or mechanical engineering background in Medical Device Capital Equipment or Medical Devices will be responsible for resolving Manufacturing and Supplier related issues of ASP products and will devise and implement methods and procedures for inspecting testing and evaluating production
- Provide technical QA support to assigned inspection and manufacturing area(s)
- Participate in process evaluations (e.g. FMEAs) develop and execute manufacturing process valuations will determine appropriate sampling plans for subsequent routine production and will participate in the training of new and lower level quality engineers
- Responsible for communicating business related issues or opportunities to next management level
- Perform other duties assigned as needed
Experience:
- Experience with nonconformances. FMEAs and CAPAs is required
- Working knowledge of first article inspection incoming/ inprocess inspections lot release testing and sampling plans required
- Experience in a FDA regulated environment preferred
- Experience with Medical Devices highly desired Prior experience with FDA audits would be a plus
- Experience working with cross functional teams such as Engineering Operations Supply Chain Suppliers New Product Development etc is desired
- Experience with reading and interpreting mechanical drawings preferred Ability to lead and/ or mentor others highly desired
- Any quality related certifications or trainings would be a preference
Qualifications:
- Minimum of 6 years related experience OR a minimum of a MS degree with a minimum of 4 years related experience OR a PhD with a minimum of 2 years related experience is required. Preferred 8 years of experience
Internal Interactions:
- Lead Core Teams
- May directly or indirectly manage Analysts Quality engineers Interns or support personnel
- May collaborate with R&D PM Supplier Quality and Operations on NPD/LCM projects. This may include protocol/report approval
External Interactions:
- May interface with contract laboratories on behalf of ASP
- May interface during audits with regulatory agencies or customers
Travel Expectations:
- 1020 Domestic
Employment Type
Full-Time
Department / Functional Area
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