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, CAPA process, internal and external audits, data analysis 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.

• Participate in quality system activities and support internal and external audits as a Subject Matter Expert (SME) for NCR and CAPA Processes

• 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

• Manage the NCR/Rework System

• Work cross-functionally with other teams to track and manage NCR/Rework/Deviation activities from initiation through closure

• Assist with affected product identification, segregation, investigation and final disposition

• Conduct periodic meetings of the Material Review Board (MRB) to present NCR trends, reports and any additional data analysis as requested

• Identify and implement QMS system continuous improvement activities to the NCR process

• Maintain NCR procedures and records per procedure requirements

• Manage CAPA process o Work cross-functionally with other teams to track and manage CAPA activities from initiation through closure

• Assist CAPA Owners with CAPA initiation, root cause investigation, CAPA actions development, tracking of CAPA actions to completion, effectiveness plan developments, review and closure of CAPA records

• Conduct periodic meetings of the CAPA Board to present new CAPAs, status of active CAPAs, CAPA trends, reports and any additional data analysis as requested o Identify and implement QMS system continuous improvement activities

• Maintain CAPA procedures and records per procedure requirements

• Compile quality metrics for trending purposes o Compile data and prepare presentations as needed for periodic reviews of the following Quality systems: NCRs, CAPAs, Rework, 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

Requirements

• Bachelor’s degree and a minimum of 2+ years 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.

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.