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Test Verification Manager (Medical Devices)

  • Anywhere

Company :
Qualitest

Location :
Concord, California

Expiry Date :
Thu, 22 Jul 2021 23:59:59 GMT

Apply Job :
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Description :
Are you interested in working with the largest independent software testing company? Read on!

QualiTest is looking for Test Verification Manager (Medical Devices) in Concord, CA to join our rapidly expanding team!

* Deliver system, software, and design verification results (plans, protocols and reports) for projects per program schedule and with high quality standards.
* Deliver anomaly and bug reports with all appropriate information whenever discrepancies are discovered.
* Maintain complete transparency on status, progress, schedule, cost, delays, risks, threats, resource issues, training deficiencies, and discrepancies of all assigned verification efforts.
* Forecast and communicate team resource and personnel needs
* Forecast the need for other resources such as lab environment, material, and equipment
* Assure team maintains size and expertise commensurate to scope and type of work
* Screen and Interview candidates for new positions and replacements on team
* Continuously provide transparency to projected and current needs of the team.
* Continuously provide transparency to the screening and interview process of candidates
* Foresee and communicate technical, schedule and other programmatic risks and issues
* Take appropriate steps to mitigate risks and eliminate issues
* Continuously provide transparency to risks, threats, and issues
* Manage to completion all tasks assigned to team on time
* Manage to complete verification of all requirements assigned to team on schedule
* Plan and manage the development, dry runs, reviews, and formal execution of verification protocols
* Manage the development of verification plans and verification reports
* Assure discrepancies, anomalies, and bugs are appropriately and immediately reported out when discovered
* Follow and assure team adheres to all design control requirements, standard operating procedures, and best practices for software and system verification at FMC
* Continuously provide transparency to all team activities, status, accomplishments, setbacks, and projection
* Participate in project planning meetings and maintain awareness of project issues, activities, and risks
* Conduct verification team meetings to (at a minimum):

– Manage and progress verification efforts

– Delegate work to team members

– schedule verification activities

– Go over and status deliverables

– Maintain timelines
* Make decisions and effect changes within verification team
* Review and provide feedback to software and system requirements
* Allocate requirements for review among team members
* Recommend requirements that team can adopt for verification
* Provide status reports across projects
* Organize, schedule, and manage all verification team activities
* Ensure project planned activities are being met
* Ensure testing process and best practices are being followed

Requirements

* At least 10 years of experience in a regulated industry in the following areas:

– Design Verification (At least 5 of the 10 years must be in verification)

– Design & Development (Software, EE, or mechanical)

* Strong Experience in Technical Areas

– Software Development Lifecycle (IEC 62304 Medical Device Software)

– Development Methodologies

– Software Testing lifecycle

– Test Methodologies

– Design Verification

* Experience in Regulated Process & Design Controls

– Verification Process / Verification Planning / Verification Protocols / Verification Reports

* Experience with Development of Medical Devices
* 5 years of experience in Leadership / People Management

– Mentoring

– Project Planning & Scheduling (i.e. MS Project)

– Organization

– Presenting (i.e. Power Point)

– People Management

– Conflict Management

– Negotiation Skills

– Leadership and responsibility to make important decisions

Nice-to-have Skills:

* Experience in Technical Areas
* Standards:
* Experience in Leadership

* Electrical & Electronic Design and Verification
* Experience in Software Development, Testing & Verification
* Lab Bench Equipment
* Test Methodologies

* ISO 14971
* ISO 13485

* Agile & Sprint Planning

Benefits

Why QualiTest?

* 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 Test Centers.
* Take care of health with enrollment into one of our competitive medical coverage options + we offer dental and vision coverage options, Life Insurance and Disability Insurance.
* We encourage you to plan your future with our 401k program.
* Never stop experimenting and learning with our Tuition Reimbursement Program. We also offer free access to over 3000+ training courses and peer to peer mentoring support.
* Stay active and get rewarded with our gym membership fee reimbursement through our Corporate Wellness Program. Earn vacation times for attendance achievements each month!
* We offer a competitive package of time off which includes vacation, sick, and mental health days. Recharge, refuel and take the time you need, when you need it.
* Celebrating your achievements and milestones are important to us so we created our Employee Rewards and Recognition Programs. Be rewarded and acknowledged for what you do and who you are!
* Earn bonus via our Client Referral and Employee Referral Programs. 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!
* 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.

Intrigued to find more about us?

* Visit our website at [
* Check out our Career page: [

If you like what you have read, send us your resume and lets start talking!