Description Are you interested in working with the largest independent software testing company?
Read on QualiTest is looking for Quality Engineer (Medical Device) to join our team in Redwood City , CA The Senior Quality Engineer is responsible for the quality assurance of product design and supplier controls / performance.
He / she must understand and be able to implement the relevant requirements of the Quality System Regulation (21 CFR 820) and ISO 13485.
Initiates and facilitates improvements to the quality system while providing technical support to R&D, Manufacturing, and Supply Chain.
Also responsible to support R&D and Operations during all product development phases and support creation of design controls as well as process qualification/validation activities, statistically sound sampling plans and process control plans including inspection/test method development and product investigations resulting from field complaints.
Ensures that vendors / suppliers deliver quality products, materials, and services in accordance with specifications, purchase orders, and quality agreements.
Monitor parts from purchasing through the manufacturing cycle.
Communicates and resolves supplier-related problems as they occur.
Assists in evaluating suppliers’ performance and provides feedback.
Supports activities associated with supplier quality within a medical device environment.
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.
Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements.
Support new product introduction projects through development and execution of process validation and verification test plans, protocols, and report.
Perform DHF/DHR review for product release Assist the Quality Department on an as-needed basis.
Requirements Must understand and be able to implement the relevant requirements of the Quality System Regulation (21 CFR 820) and ISO 13485 Experience with the creation of Procedures, Protocols, Test Reports, and Work Instructions Quality engineer not testing role.
Must have regulatory environment experience.
Must have hardware & regulation process’ experience.
Excellent organizational, problem-solving, and analytical skills Excellent verbal & written communication skills Benefits Why Quali t est?
Be a part of a company who strives to support for diversity and inclusion in the workplace – we are one, we are many at Qualitest.
Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences.
Local and global opportunities – we offer you internal rotation and international mobility opportunities to grow your career.
Clear view of your career and progression with the company – Qualitest is growing massively (since Jan 2021 – added more than 2000 engineers) and giving you the opportunity to grow with us.
Work hard and play harder with our flexible and casual culture.
Take a break from work and join an employee event, or enjoy the amenities and games provided from one of our Employees Centers.
Save your earnings and prepare for your future by enrolling in our 401k plan where Qualitest will match your contributions accelerating your savings plan.
Take care of health with enrollment into one of our competitive healthcare benefits.
Qualitest will match towards your HSA if you choose to participate.
Never stop experimenting and learning with Qualitest Tech academy: Tuition Reimbursement Program, 3000 training courses, mentorship programs, technical tribes, sponsored certifications, leadership programs and much more Stay active and get rewarded with our Corporate Wellness Program.
We pay your Gym membership and giving you opportunities to Earn additional vacation times for attendance the gym We invest in our Senior Engineers and leaders with our Equity program Earn bonuses via our Client Referral and Employee Referral Program’s.
Refer and earn – tap your network for net-worth.
Planning a vacation?
Looking for car insurance?
Get access to Qualitest Employee Perks for discounts on anything from travel to electronics.
With so many offerings the savings are endless Intrigued to find more about us?
Visit our website at www.qualitestgroup.com Check out our Career page: https://qualitestgroup.com/careers/ If you like what you have read, send us your resume and let’s start talking