QA Manager
Proteus Digital Health - Redwood City, CA

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Finding a good job in a dynamic, growing company is great.

Finding a great job in a world-changing organization is a once-in-a-lifetime opportunity.

Welcome to Proteus Digital Health, which is pioneering a new category of products, services and data systems based on ingestible computing. Our core technology – the digital health feedback system – provides an unprecedented view into an individual’s personal health choices and physiologic response. This care-altering feedback system enables patients to better manage their health, allows more effective collaboration with caregivers and clinicians, all while enabling new information-based business models.

Think You Measure Up? What Amazon did with books, and Apple did with music, Proteus is poised to do with digital medicine. Come join our unique collection of innovative scientists, engineers, market makers, designers, doctors, developers, clinicians, and other digital health industry pioneers, and help us dramatically improve the lives of tens of millions across the globe.

We Are Seeking:

Job Title: QA Manager

Department: Quality Assurance

Reports to: Director, Quality Assurance

Status: Exempt

The Quality Assurance Manager is responsible for the design and implementation of policies and procedures to ensure that quality s tandards are met during development and production. Familiar with a variety of the field's concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. Leads and directs the work of others. A wide degree of creativity and latitude is expected.

Responsibilities:
  • Accountable for ensuring full quality and regulatory compliance of a facility, while driving process effectiveness and efficiency

  • Ensures site audit readiness; prepares Quality Management System reviews

  • Has authority to stop production, issue product holds (stop orders), release products and sign off on project milestones

  • Maintains oversight of the complaints and daily processes to ensure issues are being addressed in a timely and thorough manner and conform to complaint policy and procedures

  • Technical expertise will revolve around the knowledge of FDA’s GMP regulations (QSR 820 and 210/211) and ISO13485

  • Develop metrics to ensure product assurance issues are dealt within the timeframes established by our corporate-wide product assurance goals

  • Implement product/process validation requirements with R&D and Manufacturing groups (pilot and scale-up to commercial volume)

  • Lead the MRB activities and contribute to closing of NMRs/Deviations/CAPAs

  • Conduct internal audits to ISO13485 and FDA’s QSR/QSIT processes. Manage and contribute to closure of internal and external audit findings

  • Create document ownership/training program for SOP, MPI, WI level documents. Work with and train Engineers on FDA and ISO13485 regulations

  • Interface with suppliers, partners, contract manufacturers on a regular basis, including supplier and contract manufacturer qualification, audit suppliers. Manage Supplier Corrective Action Required process

  • Responsibilities at multiple sites (within 15 miles in the Bay Area)

Are You a Fit?

Required Skills:
  • Requires high degree of technical comprehension of appropriate ISO and FDA medical device regulations, safety standards and regulatory compliance guidelines.

  • Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes

  • Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement

  • Demonstrated collaboration, negotiation & conflict resolution skills

  • Strong experience in technical support and complaint handling, reporting and trending.

  • Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.

  • Requires strong written, oral and interpersonal skills to be able to effectively interface interdepartmentally.

  • Educates and mentors local staff on quality, regulatory regulations and compliance issues.

  • Plans, organizes, and prioritizes own work routine to meet established schedule and support the activities of Product Assurance.

  • Proficient computer skills in word processing, and spreadsheets.

  • ASQ certifications for CQE, CQA, or equivalent highly recommended.

  • Technical writing proficiency (e.g., protocols, analytical reports, DCOs, SOPs, Test Methods, procedures)

  • Solid problem analysis and decision-making ability and leadership skills.

  • Integrity: Accepting & adhering to high ethical, moral & personal values in decisions, communications, actions & when dealing with others

  • 6-8 years of related work experience in a regulated industry. Clinical experience a plus.

Education: Bachelor of Science/Arts degree or related area of study

Ready for the ride of your life? We’re looking forward to receiving your resume!

About Us: Proteus has received FDA market clearance in the U.S. and a CE mark in Europe for its wearable and ingestible sensor devices. Headquartered in Redwood City, Calif., Proteus is privately held and funded by Carlyle, Essex Woodlands, Kaiser Permanente, Medtronic, Novartis, Otsuka, Oracle, ON Semiconductor and other investors. For more information please visit www.proteus.com.

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