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Quality Engineer
Company | Abbott |
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Location | Santa Clara, CA, USA |
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Salary | $79500 – $138700 |
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Type | Full-Time |
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Degrees | Bachelor’s |
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Experience Level | Mid Level |
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Requirements
- Bachelor’s degree in Engineering or equivalent or a related field.
- 2-3 years (+) experience in Quality Assurance/Quality Engineering from medical device or pharmaceutical industry.
- Sufficient knowledge in test method validations & statistical analyses.
- Regulations experience in any: 21 CFR 820, FDA, 13485, 14971.
- Proven experience in relevant areas of Quality, Regulatory or Engineering, preferably within a medical device environment.
- Advanced knowledge of relevant regulations is required to act as a resource for colleagues.
- Must be able to take accountability with excellent follow up and follow through.
- Strong written and verbal communication skills and ability to collaborate effectively.
- Capable of producing results working unsupervised under own initiative.
- Must be an effective team player with the ability to mentor, lead and problem solve to provide solutions to the business.
- Confident and open personality who is able to communicate effectively, both written and orally with people at all levels.
Responsibilities
- Plans for, executes and documents test method validations for receiving inspection methods and in-house manufacturing inspection methods.
- Supports receiving inspection and/or in-house manufacturing as applicable and necessary.
- Supports equipment/tooling asset managements, such as the handling of new creations, deactivations, calibration or preventative maintenance issues, and/or documentation of loss assessments.
- Supports or owns executions of non-conformance reports, which may include the preparation of associated metrics.
- Liaises with other Abbott sites to ensure compliance to quality system.
- Works within a GMP environment and documents results per GDP standards. Holds R&D, and operations accountable to GMP and GDP requirements.
- Supports sterilization activities and documentation (submission forms, LAL, Bioburden, etc.)
- Leads cross-functional teams to achieve consensus for deliverables associated with quality issues.
- Maintains inspection procedures for the inspection of incoming materials, in-process materials and finished goods. Select appropriate inspection, test and measurement equipment, fixtures, and gauges.
- Ensures compliance with all procedures and all applicable regulatory agency requirements.
- Identifies continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization.
- Works with engineers and manufacturing to transfer technical information into easy to understand written form, as well as take a hands-on approach to learning and documenting the processes.
- Other duties as assigned.
Preferred Qualifications
- Experience with equipment/tooling management logistics a plus.
- Experience with external/internal audits and EtO Sterilization a plus.