Senior Quality Engineer

JOB SUMMARY

The Senior Quality Engineer is responsible for the quality, safety, and reliability of THINK Surgical products. This role requires expertise in supplier, design, manufacturing, and software quality engineering. The engineer must demonstrate an understanding of consumables and sterilization processes. The Senior Quality Engineer must have deep understanding and ability to effectively and efficiently apply the applicable requirements such as 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 skillsets 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. This position is based in the Fremont, CA Office.

DUTIES & RESPONSIBILITIES

• Proactively investigate, identify, and implement best-in-class Quality Engineering practices.
• Provide quality engineering expertise in supplier management, design control, manufacturing, software quality, and sterilization activities.
• Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities.
• Act 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 THINK procedures and external standards (e.g. EN 14971).
• Participate in Usability Engineering and planning documentation (e.g. EN 62366/ISO 62366,).
• Contribute in software documentation according to IEC62304, biocompatibility testing according to applicable regulations and standards including ISO10993, and EMC testing according to IEC60601-1.
• Interface with the other project team members 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 THINK Surgical 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 devices manufactured at THINK Surgical.
• 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.
• Support new product introduction projects through development and execution of process validation and verification test plans, protocols and reports.
• Perform DHF/DHR/DMR reviews 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.
• Mentor and guide junior engineers and other QA team members, fostering knowledge development in quality engineering practices.
• Assist the Quality Department on an as-needed basis.

SUPERVISORY RESPONSIBILITIES

• N/A

QUALIFICATIONS

Required:

• 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, and serviceability.
• Proven experience managing quality in supplier, design, manufacturing, and software engineering environments.
• Demonstrated knowledge of consumables, sterilization processes, and associated regulatory requirements.
• 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, and 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 and 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, computer skills, and use of documentation programs such as Microsoft Office, Excel, Access, PowerPoint.
• Experience in supporting quality audits and FDA inspections.
• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.

Preferred:

• Certified Quality Engineer.
• Certified ISO 13485 Lead Auditor.
• Experience with medical device hardware, electrical, and software development.
• Strong background in process validation, risk management, and quality assurance for sterile devices and disposables.
• Experience with sterile medical instrumentation and disposables in a regulatory environment.
• Strong knowledge of fundamental quality and statistical tools.

COMPETENCIES

• Drives results
• Optimizes work processes
• Decision Quality

PHYSICAL DEMANDS & WORK ENVIRONMENT

• Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
• Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
• Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
• Occasionally work around moving mechanical parts.
• Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.
• Must be able to travel as business necessitates (up to10%).

Disclaimer:

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be possible to enable individuals with disabilities to perform the essential functions.