Senior Quality Engineer
Location: Fremont, CA.
Job Type: Full Time - Hybrid
The Senior Quality Engineer is responsible for the quality, safety, and reliability of products. The Senior Quality Engineer must have deep understanding and ability to effectively and efficiently apply the relevant requirements of the Quality System Regulation (21 CFR 820) and ISO 13485. They must have a passion to spearhead and lead the effort to develop, maintain, and continuously improve our standard practices while proactively providing cross-functional support. This individual will act as the Quality representative on current and/or new product development, taking initiative to influence, coach, and mentor teams appropriately. An ideal candidate will have a high level of technical skill sets and depth of knowledge to support the development of complex medical robotics. Other responsibilities include supporting products throughout all development phases, test protocol development, process qualification/validation activities, the creation of statistically sound sampling plans, product investigations, and other quality processes.
DUTIES & RESPONSIBILITIES
- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
- Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities.
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Work with product development teams to develop measurable goals for quality
- Participate in the risk management process ensuring, when applicable, that hazards are adequately mitigated in product and process quality plans in accordance with all procedures and external standards (eg. EN 14971)
- Participate in Usability Engineering and planning documentation (eg. EN 62366/ISO 62366,)
- Contribute in software documentation according to IEC62304, biocompatibility testing according to ISO10993, and EMC testing according to IEC60601-1
- Interface with the core team and support the development effort for both product and packaging designs.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues
- Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the products
- Support new product introduction projects through development and execution of process validation and verification test plans, protocols, and report
- Plan and direct creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished manufactured devices
- Ensure process compliance through the design and development of quality plans, procedures including work instructions, flowcharts, forms, templates, checklist and other product or process related documentation, for recording, evaluating, and reporting quality data
- Supports new product introduction projects through development and execution of process validation and verification test plans, protocols and reports
- Perform DHF/DHR review for product release.
- Provide quality expertise post market release to the quality engineering support team to analyze the returned product
- Perform technical failure analysis based on the physics of failure.
- Assist the Quality Department on an as-needed basis.
- Performance management
- Bachelor's degree (or equivalent experience) with 7 plus years of related experience
- Ability to manage priorities and workflow in a rapidly changing environment
- Proven experience in design for reliability, manufacturability, serviceability
- Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485
- Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, production process control methodologies in a medical device environment
- Previous work experience with product design changes, process verification and validation, as well as production process controls methodologies in an FDA/ISO regulated environment
- Excellent organizational, problem-solving, and analytical skills
- Excellent verbal & written communication skills
- Excellent interpersonal and communication skills with the ability to develop trust, respect and confidence with internal and external customers.
- Proficient technical writing skills and use of documentation programs (Example Office Windows, Excel, Access, Power Point, etc.).
- Experience in supporting quality audits and FDA inspections
- Certified Quality Engineer
- Certified ISO 13485 Lead Auditor
- Experience with medical device hardware, electrical, and software development
- Experience with sterile medical instrumentation and disposables, in a regulatory environment
- Strong knowledge of fundamental quality and statistical tools