RR Donnelley

Supervisor - Quality Assurance

RR Donnelley$67K — $105K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • High School Diploma or GED with at least 5 years in quality assurance within a production environment.
  • Bachelor’s degree in a technical or life sciences field is preferred.
  • A minimum of five years’ experience in a QA role with at least one year in a leadership position.
  • Experience in a regulated environment such as medical device manufacturing is preferred.
  • Strong understanding of ISO 9001, 13485 (and familiarity with 21 CFR820) is highly desired.
  • ERP system exposure (JD Edwards a plus) and proven presentation skills to executive management.
  • Excellent oral and written communication skills with the ability to work collaboratively in a matrix organization.

Responsibilities

  • Plan and implement quality programs that adhere to customer requirements and established standards.
  • Drive a culture of continuous improvement across the organization.
  • Supervise a team that includes software quality engineers, trainers, and quality specialists.
  • Maintain and update quality documentation based on ISO 9001:2015, ISO 13485:2016, and FDA guidelines.
  • Coordinate with internal and external customers to meet production requirements, schedules, and product quality.
  • Investigate customer complaints and recommend improvements for testing, product quality, or processes.
  • Ensure all departmental staff receive the necessary training and maintain effective communication across departments.

Benefits

  • Medical, dental, and vision coverage.
  • Paid time off.
  • Disability, life, and supplementary insurance coverages.
  • 401(k) plan with company match.
  • Parental leave and adoption assistance.
  • Tuition assistance along with employer/partner discounts.
Full 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 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

RRD is seeking a skilled Quality Assurance Supervisor for our Houston, TX facility!

Job Summary

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 our clients and in compliance with the ISO 9001: 2015 and ISO 13485, reporting to Director Quality and Regulatory Affairs.

Responsibilities
  • Plan and implement programs that ensure quality according to the requirements and guidelines of customers and in compliance with quality standards.
  • Helps drives the culture of continuous improvement.
  • Oversees 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.
  • Supports the risk based approach to the site QMS and operations.
  • 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.
  • Foster the continual use and implementation of the philosophies and tools that are taught through our Total Quality Program.
  • 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.
  • Responsible to follow up and ensure that the personnel of the Department have the proper training to perform the job duties.
  • Ensures adequate operational quality controls are developed to incorpórate customer and regulatory requirements.
  • Perform other related duties as required.


Qualifications
  • High School Diploma or GED, with 5 years or more experience working in a quality assurance or similar role within a production environment.
  • Bachelor's Degree in a Technical or one of the Life Sciences field is preferred.
  • Minimum five years of experience working in a Quality Assurance or similar role.
  • Minimum of one year's experience in a formal Leadership role.
  • Experience in medical device manufacturing or similarly regulated environment is preferred.
  • Must be confident in their 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.
  • The incumbent is required to demonstrate a positive attitude on a consistent basis when working with others.
  • 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

RRD's current salary range for this role is $67,800 to $105,800/ 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.

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RRD is an Equal Opportunity Employer, including disability/veterans

About RR Donnelley

RR Donnelley is a global provider of integrated communications. The company works collaboratively with more than 60,000 customers worldwide to develop custom communications solutions that reduce costs, drive top-line growth, enhance ROI and ensure compliance. The company provides a broad range of services in commercial printing, direct mail, financial printing, print fulfillment, labels, forms, logistics, call centers, transactional print-and-mail, print management, online services, digital photography, color services, and content and database management to customers in the publishing, healthcare, advertising, retail, technology, financial services and many other industries.
Learn more about RR Donnelley
Size
32,000 employees
Market Cap
$790.2 million
Industry
Net Income
$98.5 million
Founded
1864
5 Year Trend
-6.2%
Revenue
$5.1 billion
NASDAQ

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