Manager, Quality Assurance & Regulatory Affairs

About the Position

We are seeking a Manager for Quality Assurance & Regulatory Affairs to oversee the implementation, maintenance, and continuous improvement of the site Quality Management System (QMS) and regulatory compliance for assigned locations. This role works with site management and personnel to ensure sustainable compliance to customer, state, federal, and international regulatory requirements within highly regulated markets such as medical device and FDA.

Responsibilities

• Provides ongoing leadership and support in maintaining and continually improving the site Quality Management System (QMS) and processes inclusive of food, Medical Device / Pharma manufacturing.
• Manages a team of Quality Engineers, Supervisors, Specialists, and Auditors.
• Manages software quality activities.
• Leads product release for medical devices.
• Provides guidance to sites for process validation strategies.
• Coordinates activities to maintain relevant Quality System requirements such as ISO 13485:2016, 9001:2015, ISO 14971, ISO 11137, EUMDR, and FDAQSR.
• Informs site Management of significant or potentially significant quality issues, and facilitates effective root cause analysis and corrective/preventive actions to reduce or eliminate errors.
• Monitors and measures QMS processes, including Quality Objectives, CAPAs, NCMRs, and Preventive Actions.
• Works with customers and suppliers to develop and approve Quality agreements.
• Implements the risk-based approach to the site QMS and operations.
• Manages quality plans for large changes and implementations.
• Leads the organization and implementation of new products.
• Manages the implementation of and the ongoing monitoring for the Clean room and environmental product controls coordinating with the Sterilization vendor.
• Oversees the effective use and further implementation of eQMS systems.
• Interacts with customers and assists with quality-related responses to RFP’s/RFI’s for the site.
• Leads and manages the internal audit process.
• Provides leadership and direction to quality department employees.
• Ensures all deviation investigations are appropriately investigated and recorded.
• May manage Quality and Regulatory staff at more than one site.
• Other duties and responsibilities as assigned.

Requirements

• Bachelor's Degree in a Technical or one of the Life Sciences fields.
• 5+ years of related work experience including Team Leadership experience.
• 3 years of Medical Device or Pharma QA or RA experience.
• Advanced training or experience in ISO 13485:2016, ISO 14971:2019, and FDA QSR required.
• Ability to understand and interpret federal regulations and company operating procedures as they apply to manufacturing regulated products.
• Experience with ISO class cleanrooms and qualification for sterile production is desirable.
• Must be able to prioritize and multi-task with minimal supervision.
• Knowledge of USDA Organic food manufacturing requirements.
• ISO Lead Auditor certification or ASQ Certified Auditor.
• Knowledge of PC systems and Microsoft Office Suite (Word, Excel) required.
• Excellent written and verbal communication skills.

Nice to Have

• Certification in 13485.

We Offer

• Competitive salary range: USD 107,000 - USD 171,200 / year.
• Comprehensive benefits package including medical, dental, and vision coverage, paid time off, disability insurance, 401(k) with company match, life insurance, and other voluntary supplemental insurance coverages.
• Parental leave, adoption assistance, tuition assistance, and employer/partner discounts.

About the Company

RRD is a leading global provider of marketing, packaging, print, and supply chain solutions that elevate engagement across the complete customer journey. The company offers the industry’s most trusted portfolio of creative execution and worldwide business process consulting, with services designed to lower environmental impact. With 22,000 clients, including 93% of the Fortune 100, and 32,000 employees across 28 countries, RRD brings the expertise, execution, and scale designed to transform customer touchpoints into meaningful moments of impact.

RRD is an Equal Opportunity Employer, including disability/veterans. We value innovation, authenticity, and integrity. To uphold the security and fairness of our hiring process, we ask that candidates refrain from using AI tools during interviews to ensure an authentic and secure experience. We appreciate your cooperation as we work to maintain a transparent and equitable hiring process.

All employment offers are contingent upon the successful completion of both a pre-employment background and drug screen.