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Description

Position Overview In compliance with FDA, European MDD/MDR & ISO regulations, the Quality Compliance Specialist will perform work under supervision. General scope of this position is to support NCR process, Data analysis, internal and external audits, Service Order Records, Supplier files and monitoring of the of key process metrics. This position requires frequent use and general knowledge of industry practices, techniques, and standards. Essential Job Functions  Assist with audit activities. o Participate in quality system activities and support internal and external audits. o Coordinate audit related activities (prepare documents, track audit requests, take notes, schedule conference room, setup communication channel etc.) o Interface with Subject Matter Experts regarding the audit requests.  Assist with managing the NCR/Rework/Deviation System o Work cross-functionally with other teams to track and manage NCR/Rework/Deviation activities from initiation through closure o Assist with affected product identification, segregation, investigation and final disposition o Identify and implement QMS system continuous improvement activities o Maintain records per procedure requirements  Assist with Supplier Controls o Initiate and maintain supplier files on the Approved Supplier List. o Gather information and update as needed to ensure supplier files are current and in compliance with Shockwave Medical Supplier procedures.  Manage Service Orders Request (SOR) o Keep a record of the SORs activities o Make sure that the NCRs materials are managed to comply with 30 days post receipt requirements o Maintain the full record of all the SOR repairs and Cost associate with repairs.  Compile quality metrics for trending purposes o Develop, implement and maintain SORs data logs. o Compile data and prepare presentations as needed for periodic reviews of the following Quality systems: SORs, Costs per SOR, etc.  Work cross-functionally with other teams to compile and generate periodic reports in a timely manner to support quality systems activities.  Work cross-functionally with other teams in tracking and ensuring Quality Objectives published during Management Reviews are met.  Support company goals and objectives, policies, and procedures, QSR, and FDA regulations.  Other duties as assigned.

Skills

Compliance, Audit, Data entry, Quality assurance, NCR, Gmp

Top Skills Details

Compliance,Audit,Data entry,Quality assurance,NCR

Additional Skills & Qualifications

Requirements  Bachelor’s degree and a minimum of 2 year of related experience in the medical device industry.  Experience with FDA/ISO Audits, NCR, and CAPA experience is a plus.  Ability to compile and analyze data, present information, and demonstrate competent document writing skills.  Excellent written and verbal communication skills.  Basic knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems.  The ability to understand and follow QMS Procedures. (e.g., SOP and Test Methods.)  Experience with computer-based applications (MS Word, MS Excel, Power Point).  Strong time management skills and the ability to multi-task in a fast-paced environment.  Operate as a team and/or independently while demonstrating flexibility to changing requirements.

Experience Level

Entry Level

Pay and Benefits

The pay range for this position is $36.00 - $41.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Santa Clara,CA.

Application Deadline

This position is anticipated to close on Jun 7, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.