Quality Systems Coordinator
Do you have medical device experience? Are you interested in neuromodulation?
Neuspera Medical is looking for a Quality Systems Coordinator.
Location: Neuspera Medical, Inc. Headquarters in San Jose, CA
Reporting to: Director of Quality
Base Pay: Negotiable
Employment Type: Full-Time
Job Type: Individual Contributor
Experience: At least 7 years
Manages Others: No
Industry: Medical Devices
Required Travel: Occasional
ABOUT NEUSPERA MEDICAL, INC.
Neuspera Medical Incorporated is an exciting medical device startup company headquartered in San Jose, CA that is committed to bringing forward implantable medical device technology that will improve lives of patients battling with chronic illness.
Assume overall responsibility for all aspects of Document Control and Training coordination functions consistent with Neuspera Quality Manual and applicable SOPs. Administrative responsibility for key Quality System processes. Participate in additional QA/Operations support tasks as required. Supports Quality Assurance, R&D, and Manufacturing Operations in accordance with quality system procedures. This position performs in-process, and final Quality inspections and other related activities.
- Process documentation changes: manage the initial release of QS documents and revision of existing documents, managing the DCO reviews, and releasing documents within an electronic Quality Management System (eQMS)
- Promptly respond to questions and issues raised by Originators and Approvers
- Provide continuous improvement of Document Control processes/procedures
- Review records and documents, for completeness and compliance with QSR and ISO requirements
- Ensure the eQMS operates effectively and efficiently to meet the needs of internal customers, business objectives, and Company Quality objectives
- Maintain library of the purchased external standards and organize their electronic and paper filing such that it is easy for the user to find any standard by title or description. Interact with the supplier for revision notification
- Maintain employee and consultant training records (internal and external) and tracking system
- Overseeing maintain the Training Program with an emphasis on continues improvement and system effectiveness and efficiency to meet the changing needs of the business
- Collaborate with Department managers to ensure training plans are prepared for all new hires an updated as appropriate for current employees
- Ensure employees and consultants are trained to all required procedures and follow up to confirm continued training to latest revisions
- Develop a training library to promote learning throughout the organization
- Perform in-process and final inspection of in-house manufactured product per established SOP requirements, traveler instructions, and/or documents referenced in the traveler
- Develop and maintain Quality Management System in accordance with company standards & regulatory requirements
- Participate in Management Review meetings and assist in gathering, preparing, analyzing and presenting data to executive management on the performance of the Quality Management System
- Maintain and file equipment maintenance and calibration records in a database
- Coordinate equipment maintenance/calibration with maintenance/calibration suppliers
- Provide support by reviewing and ensuring timely completion and closure of Non-Conformance Reports (NCR), CAPAs and Supplier Corrective Action Reports (SCAR)
- Initiate and process NCMRs for non-conforming materials/products
- Prepare for, participate in, and respond to Internal/External Quality/Regulatory Audits
Qualifications and Experience:
- BS or BA degree or related practical experience preferred
- Document Control experience is preferred
- Experience with an electronic Quality Management System (eQMS) a plus
- At least 7 years of experience in FDA/CE regulated medical device industry
- Must be proficient with MS Word, Excel and Adobe Acrobat. Experience with Database such as Access is a plus
- Good oral and written communication skills
- Must be very well-organized and must have passion for details and accuracy
- Ability to work independently, prioritize activities, communicate well, and drive toward achieving department performance metrics
- Foster work culture of:
- Diversity and Inclusion
- Honesty and Integrity
- Accountability and teamwork
- Proactive communication focused on results that is based on facts and is respectful
The base salary range for this position is $97,000-$118,000, plus bonus eligibility, equity, and benefits. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all locations. Within the range, individual pay is determined by factors including job-related skill level, work experience, relevant education or training, and location.
- Office and Laboratory
- Some travel necessary
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