Description:

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

o 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.

o 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

o 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.

o 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.

o 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.

o Work cross-functionally with other teams to compile and generate periodic reports in a

timely manner to support quality systems activities.

o Work cross-functionally with other teams in tracking and ensuring Quality Objectives

published during Management Reviews are met.

o Support company goals and objectives, policies, and procedures, QSR, and FDA

regulations.

o Other duties as assigned.

Skills:

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

Additional Skills & Qualifications:

o Bachelor’s degree and a minimum of 2 year of related experience in the medical device

industry.

o Experience with FDA/ISO Audits, NCR, and CAPA experience is a plus.

o Ability to compile and analyze data, present information, and demonstrate competent

document writing skills.

o Excellent written and verbal communication skills.

o Basic knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems.

o The ability to understand and follow QMS Procedures. (e.g., SOP and Test Methods.)

o Experience with computer-based applications (MS Word, MS Excel, Power Point).

o Strong time management skills and the ability to multi-task in a fast-paced environment.

o Operate as a team and/or independently while demonstrating flexibility to changing

requirements.

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.