Manager, Quality Assurance & Regulatory Affairs

About the role

The Manager - QA/RA will oversee the implementation, maintenance and continuous improvement of the site Quality Management System and the Regulatory affairs for assigned locations. Works with site management and personnel to plan, develop, implement and continually improve site relevant QMS requirements, and to ensure sustainable compliance to customer, state, federal and International regulatory requirements within highly regulated markets such as medical device and FDA.

Essential Duties and Responsibilities

• Provides ongoing leadership and support in maintaining and continually improving of site Quality Management System (QMS) and processes inclusive of food, Medical Device / Pharma manufacturing.
• Manages team of Quality Engineers, Supervisors, Specialists and Auditors.
• Manage software quality activities.
• Lead product release for medical devices.
• Provide guidance to site(s) 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 Objective, CAPAs, NCMRs and Preventive Actions.
• Work with customer and suppliers to develop and approve Quality agreements.
• Implements the risk based approach to the site QMS and operations
• Manage 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.
• Oversee 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 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.

Qualifications & Requirements

• Bachelor's Degree in a Technical or one of the Life Sciences field.
• 5+ years related work experience including Team Leadership experience
• 3 years 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 product.
• 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.

Certification in 13485 desirable.

Additional Information

RRD's current salary range for this role is $107,000 to $171,200 / year. The salary range may be adjusted based on the applicable geographic location of the hired employee, and the range may change in the future.

At RRD, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions may vary based upon, but not limited to education, skills, experience, proficiency, performance, shift and location. Depending on the role, in addition to base salary, the total compensation package may also include participation in a bonus, commission or incentive program.

RRD's benefit offerings include medical, dental, and vision coverage, paid time off, disability insurance, 401(k) with company match, life insurance and other voluntary supplemental insurance coverages, plus parental leave, adoption assistance, tuition assistance and employer/partner discounts.