Manager, Quality Assurance & Regulatory Affairs

RRD; Houston (TX); Presencial; USD 107.000 - 171.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, and vision coverage

401(k) with company match

Paid time off

Disability insurance

Life insurance

Parental leave

Tuition assistance

Employer/partner discounts

Descripción de la vacante

RRD is seeking a Manager – QA/RA to lead the site Quality Management System and Regulatory affairs for assigned locations, ensuring compliance with ISO and FDA requirements in regulated markets.

The role directs a team of quality professionals, oversees software quality and product releases for medical devices, and guides validation strategies while coordinating with customers and suppliers to maintain quality agreements.

Formación

• Bachelor's degree in a technical or life sciences field.
• 5+ years related work experience including team leadership.
• 3 years medical device or pharma QA or RA experience.
• Advanced training in ISO 13485:2016, ISO 14971:2019 and FDA QSR.
• Ability to interpret federal regulations and procedures for manufacturing.
• ISO class cleanrooms experience desirable and sterile production qualification.
• ISO Lead Auditor certification or ASQ Auditor.
• Proficient with Microsoft Word/Excel and standard PC tools.

Responsabilidades

• Lead and maintain the site's Quality Management System (QMS).
• Manage Quality Engineers, Supervisors, Specialists and Auditors.
• Oversee software quality activities and product releases for medical devices.
• Guide process validation strategies and QMS improvements.
• Ensure compliance with ISO 13485, ISO 9001, ISO 14971, ISO 11137, EUMDR and FDA QSR.
• Coordinate root cause analyses and CAPAs.
• Develop quality agreements with customers and suppliers.
• Monitor QMS metrics, CAPAs, NCMRs, and preventive actions.
• Lead internal audits and supervise quality staff across sites.

Conocimientos

Team Leadership

Regulatory compliance

Quality Management System

Problem-solving

Communication skills

Educación

Bachelor's degree in Technical or Life Sciences

ISO Lead Auditor certification or ASQ Auditor

Herramientas

Microsoft Office Suite

PC systems

Descripción del empleo

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 world-wide 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.

Job Description

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

• 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.

• 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

RRD is an Equal Opportunity Employer, including disability/veterans

At RRD, 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.