Title: Manager Quality Engineering
This position is based in our Campbell, California offices. This position is on-site, full-time.
Why Imperative Care?
Do you want to make a real impact on patients?
As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases. Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives. Our focus is on the needs of the patient, and they come first in everything we do.
What You’ll Do - Responsible for driving exceptional product quality, safety, design, and reliability through the R&D/Product Development cycle. This technical position will have direct influence on component, assembly, and final product quality from concept to market release. This role will actively participate and lead a technical team through risk management, design concepts, design specifications, design for quality and manufacturing requirements to ensure design projects meet all applicable quality and regulatory requirements.
- Work directly with cross functional teams to develop and execute quality engineering activities to meet commercial milestones
- Support the analysis and evaluation of business situations, production capabilities, manufacturing problems, and the design and development of new products from the quality assurance perspective
- Participate in designing and writing plans and protocols for testing of complex medical device products with R&D team
- Suggest alternative methods and procedures in solving problems and meeting quality requirements
- Review technical problems and departmental procedures and recommends solutions to problems or changes in procedures
- Provide authoritative guidance on ISO, QSR and external standards requirements to the new product development teams
- Manage all departmental employee related activities, including the day-to-day resourcing, hiring, mentoring, and on-going development to the staff
- Train and mentor engineers and other project team members on best practices in quality engineering and regulatory compliance to external standards
- Champion processes covering Quality Engineering and Quality Management to train, support, and encourage team members in the use of quality tools such as root cause analysis, risk analysis, FMECA, DOE, and statistical methods
- Provide guidance about Six Sigma principles (Sampling, Acceptance, DOE, Statistical Process Control, Root Cause Analysis, FTA, control charts, capability analysis)
- Develop and execute verification and validation plans and protocols associated with product/process quality according to FDA and ISO regulations and Verb SOPs
- Review and draft process validation plans and protocols, and conduct validation testing of new or updated products and equipment, fixtures or tools as necessary
What You’ll Bring –
minimum requirements for this role:
- BS in Engineering or related discipline and 8+ years of related experience; or MS in Engineering with 6+ years of related experience; or equivalent combination of education and work experience
- 2+ years of supervisory experience strongly preferred
- Through applied knowledge of ISO 13485, ISO 14971, IEC 60601 standards and 21 CFR 820 and MDD regulations
- Working knowledge of statistics for R&D, quality, reliability and inspection
- Exceptional working knowledge of Design Controls and External Standards applicable to complex medical device products
- Strong understanding of human factors and usability engineering
- Working knowledge of biocompatibility and sterilization validation is a plus
- Strong analytical and problem-solving skills; strong attention to detail
- CQE or CQM certification a plus
Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
Join Us! Imperative Care
Salary Range: $168,000 – 187,000 annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.
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