This Jobot Job is hosted by: Emily Olinger
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Salary: $120,000 - $130,000 per year
A bit about us:
We are a leader in specialty surgery and patient positioning including specialty surgical tables for spinal, orthopedic, trauma, and general surgery. We are looking for a QA Engineer experienced in the medical device industry. Sound like you? Apply today!
Location: Union City, CA (lot's of remote flexibility!
Why join us?
- Full Medical, Vision, and Dental (PPO and HMO)
- Bonus program
- 401k matching
- FSA, Pet Insurance, Life Insurance, AD&D Insurance
- PTO and all major holidays
- 529 College Savings Plan
- Discounts at partnered retailers (gym, phones, etc.)
- Remote flexibility!
You will be responsible for all activities involving quality assurance and compliance with applicable regulatory requirements. This position manages quality assurance programs and processes to ensure the quality of the product conforms to the established procedures and applicable regulatory requirements. This position also utilizes technical expertise on the FDA’s QSR, ISO 13485, ISO 14971, EU MDR for Class I and Class II medical devices for capital equipment and their accessories.
- Provide QA Engineering input and guidance during manufacturing, production, and design activities in support of new product introductions and modifications to existing products. The support includes but is not limited to the review and approval of validation documentation, test reports, and procedures according to change control requirements.
- Conduct Internal Audits to ensure compliance with the established procedures and applicable regulatory requirements.
- Manage the processing of Complaints and CAPAs. Act as SME for the assigned issues to contain, investigate, develop action plans, and drive to closure as required within prescribed timelines.
- Review and develop documentation for acceptance, monitoring, and validations for EO/Gamma/E-Beam sterilization and clean/controlled manufacturing environment.
- Utilize standard statistical analysis techniques to determine product acceptance: evaluate process capabilities; and develop statistically sound tolerance limits based on product specifications, recommend sampling plans, inspection methods, etc.
- Possess Equipment Qualification Experience (IQ/OQ/PQ). Provide assistance and/or perform inspection and electrical safety testing.
- To understand, follow and support our internal Quality System policies, procedures, and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations, ISO 13485 and applicable International Standards).
- Experience with Quality Assurance in the medical device industry.
- Experience with mechanical and electro-mechanical medical device manufacturing.
- Previous experience with managing quality systems: CAPA, Complaints processing, NCR, Deviations.
- Thorough knowledge of ISO standards, FDA’s QSR, MDD, and other regulations as applicable to Mizuho OSI’s product.
- Knowledge of sterilization methods for medical devices. Thorough understanding of acceptance, monitoring, and validations for EO/Gamma/E-Beam sterilization and clean/controlled manufacturing environment.
- Knowledge of engineering applications, CAD, and Solid Modeling software.
- General understanding of Geometric Dimensioning and Tolerance (GD&T) skills.
- Ability to perform basic statistical analysis, calculating C&R, create and reconcile reports, demonstrate strong analytical skills, and attention to detail.
- ASQ Certification for CQE, CQA. Auditor certification for ISO 13485 (preferred)
- Experience with lean manufacturing (preferred)
Interested in hearing more? Easy Apply now by clicking the "Apply on company site" button.