Supervisor - Quality Assurance

RR Donnelley & Sons; Thurmont (MD); On-site; USD 74,000 - 116,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Paid time off

Disability insurance

Life insurance

401(k) with match

Tuition assistance

Maternity leave

Adoption assistance

Employer/partner discounts

Job summary

RR Donnelley & Sons is seeking a Quality Assurance leader to oversee QA services and ensure compliance with ISO 9001:2015, ISO 13485, and FDA guidelines. You will manage a team of quality engineers and specialists, drive improvements, and ensure product quality meets customer expectations across our Thurmont operations.

The role emphasizes cross-functional collaboration, strong decision-making, and organization of documentation in a fast-paced manufacturing environment.

Qualifications

• Associates degree in a related field required.
• Bachelor's degree in related field preferred.
• At least six years of experience in QA with an Associate's degree OR four years with a Bachelor's.
• Confident in decision-making balancing business and quality risks.
• JD Edwards or ERP systems experience is a plus.
• Excellent oral and written communication skills.
• Knowledge of ISO 9001, 13485 and 21 CFR820 strongly preferred.
• Ability to present to top management.
• Ability to work in a matrix organization and cross-functionally.
• Problem solving ability through technical knowledge.
• Multitask and prioritize workload.
• ISO 9001 & 13485 certifications desirable.

Responsibilities

• Plan and implement programs to ensure quality according to customer requirements and quality standards.
• Oversee a team including software quality engineering, quality trainer and quality specialists.
• Assist with updating quality documentation per ISO 9001:2015, ISO 13485:2016 and FDA.
• Communicate with internal and external customers to ensure production requirements, schedules, and deliveries.
• Ensure products are licensed, produced and marketed.
• Evaluate, investigate and respond to customer complaints.
• Recommend testing or alternate products with manufacturing staff.
• Maintain daily communication with departments to follow processes and drive improvements.
• Ensure training for department personnel.
• Develop quality controls to meet customer and regulatory requirements.
• Support continual use of total quality program.
• Support risk-based approach to site QMS and operations.
• Help drive culture of continuous improvement.
• Perform other related duties as required.

Skills

Quality Assurance

Risk Management

JD Edwards

Communication Skills

Presentation Skills

Cross-functional Collaboration

Multitasking

Problem Solving

ISO 9001

ISO 13485

21 CFR820

Management Presentations

Cross-functional teamwork

ISO Certification

Education

Associate's degree in a related field

Bachelor's degree in related field

Tools

JD Edwards

Job description

Company Description

RRD is a leading global provider of marketing, packaging, print, and supply chain solutions that elevate engagement across the complete customer journey. The Thurmont Plant was opened in 1950. We are one of the biggest employers in the area with opportunities in various printing jobs and various working shifts. 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

Plan, lead and coordinate all areas of Quality Assurance Services to exceed internal and external customer expectations in safety, quality, productivity, schedules, and employee relations. The ideal candidate will organize and control the processes, procedures, policies and activities for the assurance of the quality of the products according to the guidelines established by clients and in compliance with the ISO 9001: 2015 and ISO 13485.

Responsibilities

• Plan and implement programs that ensure quality according to the requirements and guidelines of customers and in compliance with quality standards.


• Oversee a team that includes software quality engineering, quality trainer and quality specialists.


• Assist with the preparation, updating in the system of quality documentation, basing the processes on the standard of ISO 9001: 2015 and ISO 13485:2016 and FDA.


• Communicate effectively with all internal external customers to ensure that all production requirements, schedules, quality, and final deliveries of our products are satisfactory.


• Regularly ensure manufactured products are appropriately licensed, produced and marketed.


• Perform the proper evaluation, investigation and response to customer complaints.


• Make recommendations directly with manufacturing staff on the testing or trial usage of any new or alternate products and methods affecting product quality.


• Maintain daily communication with the Departments to follow the established processes and together take actions for the improvement or problems solution detected in the product or in the processes.


• Follow up and ensure that the personnel of the Department have the proper training to perform the job duties.


• Ensure adequate operational quality controls are developed to incorporate customer and regulatory requirements.


• Foster the continual use and implementation of the philosophies and tools that are taught through our Total Quality Program.


• Supports the risk based approach to the site QMS and operations.


• Helps drives the culture of continuous improvement.


• Perform other related duties as required.

Qualifications

• Associates degree in a related field required


• Bachelor's degree in related field preferred


• At least six years of experience working in a Quality Assurance or similar role with an Associate's degree in a related field OR at least four years of experience working in a Quality Assurance or similar role with a Bachelor's degree.


• Must be confident in ability to make decisions balancing business requirements with quality requirements and the associated risks.


• JD Edwards or an ERP system experience is a plus.


• Excellent oral and written communication skills.


• Knowledge in ISO 9001, 13485 and 21 CFR820 is strongly preferred.


• Must possess skills to make presentations to top management.


• Ability to work in matrix management and able to work collaboratively and cross- functionally as well as across the organization.


• Problem solving ability through technical knowledge.


• Must be able to multi-task and prioritize workload.


• Certification in ISO 9001 & 13485 desirable.

Additional Information

Thenational pay range for this role is $73,500 to $116,000 annually. The payrange may beslightly lower or higher based on the geographic location of the hired employee. The actual pay offered may vary based upon, but not limited to: education, skills, experience, proficiency, performance, shift and location. In addition to base salary, depending on the role, the total compensation package may also include participation in a bonus, commission or incentive program. RRD offers benefits including medical, dental, and vision coverage, paid time off, disability insurance, 401(k) with match, life insurance and other voluntary supplemental insurance coverages, plus tuition assistance,maternity leave, adoption assistance, and employer/partner discounts.

• All your information will be kept confidential according to EEO guidelines.


• At least 2 years in product operations, data entry, or another similar support role.


• Strong analytical skills with the ability to identify trends and communicate insights.


• Clear communication skills for engaging with cross-functional teams and presenting insights.


• Problem-solving skills for straightforward situations using judgment and established guidelines.


• Ability to prioritize tasks and manage multiple responsibilities.

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.