Associate Quality Manager, Document Control

Job Locations US-CA-Redwood City
Job Post Information* : Posted Date 1 month ago(1/3/2023 2:45 PM)
ID
2022-3943
Category
Quality

About Nevro

Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 80,000 patients globally.

 

Nevro’s comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy.  Senza®, Senza II®, and Senza Omnia™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Nevro’s unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management.

Job Summary & Responsibilities

Responsible for contributing, supporting, and maintaining the Document Control Quality System within the requirements of FDA’s Quality System Regulations (QSR) and ISO 13485 (ISO).  Ensures that product and product related documents are processed in compliance with established procedures.

  • Manage the Document Control and Record Control systems
  • Support Document Control functions and responsibilities within a Product Life Cycle Management (PLM) system.
  • Provide clear and accurate communication to internal customers. Clearly communicate both verbally and in writing, with originators when discrepancies are found. Give precise guidance to originators for the proper process to follow when to correct issues/discrepancies.
  • Provide change control support as needed to co-workers within and outside document control.
  • Create, revise and review Quality System documents to establish and maintain compliance with FDA, EU and other national and international regulations and standards.
  • Responsible for ensuring departmental SOP & WI reviews are performed per requirements.
  • Provide continuous improvement of Document Control processes/procedures in accordance with department and company goals.
  • Release and maintain QMS documents including the processing of new document and document revision requests.
    • Ensure the consistency and quality of documents by editing and proofreading documents prior to release
  • Assist with audit activities as required, including follow up activities

Metrics

  • Perform trending analysis (Quality Metrics) on a routine basis
  • Identify, generate, and publish metrics and reports related to the creation and control of quality system documentation.
  • As appropriate, analyze trends and recommends process improvements.
  • Other duties as assigned.

Role Requirements

  • Bachelor’s Degree, preferably in life sciences
  • 3+ years of experience in Quality, medical device preferred
  • Excellent word processing and verbal and written communication skills
  • Ability to work independently and in collaboration with other team members
  • Knowledge of FDA regulations for medical devices and ISO 13485

Skills and Knowledge

  • Knowledge of documentation systems, specifically new product development (protocols, reports, software, validation data, Design History Files), quality system (procedures, forms, quality records), and manufacturing (Bill of Material, routers, procedures, Device History Records, Device Master Records) documentation.
  • Experience with electronic documentation systems such as Arena, EtQ, preferred.
  • Direct experience maintaining procedures as they relate to the FDA Quality System regulations and EU regulations (ISO13485 preferred.
  • Exposure of 21 CFR Part 11 and Computer/Quality System Software management methods preferred.
  • Strong technical capability, verbal and written communication skills and effective interpersonal skills.
  • Ability to work independently with minimum oversight.
  • Ability to multitask, prioritize and meet deadlines.
  • Above average organizational skills, detail-oriented while being flexible, able to adapt to changing priorities is required.
  • Proficiency in Microsoft Office, Access, Excel, Project, as well as exposure to technical document source applications such as Adobe Acrobat, SolidWorks, and Illustrator is recommended.
  • Ability to communicate well with all levels of staff and present data to Management when needed.

#LI-LJD1

 

#LI-Hybrid

 

Target Pay Range

$103,342.00 to $142,095.00 - the final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, alignment with market data, and geography. *Nevro is a multi-state employer, so the target pay range may increase or decrease depending on the city/state.

 

Full-time Nevro team members enjoy a full suite of additional benefits such as market-leading medical, dental, and vision benefits, 401k matching, ample vacation time, pre-tax savings perks, tuition reimbursement, Employee Stock Purchase Plan (ESPP), short and/or long-term incentive opportunities, recognition awards, volunteer time off, and several employee resource groups that focus on supporting our Wellness, Leadership Development, and Diversity and Inclusion.”

EEO Statement

Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, protected veteran status, disability, age or other characteristics protected by laws.

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