Job Description

RR Donnelley is hiring a Quality Assurance Manager at our Plover, WI location!

RRD - Plover, WI is a medical device contract manufacturing facility. The Quality/Regulatory Manager is responsible for directing, planning, organizing and controlling the processes, procedures, policies and activities for the assurance of the quality of the products according to specifications and in compliance with FDA 21CFR820 & ISO 13485, reporting to Director Quality and Regulatory Affairs.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

1. Plan and implement programs that ensure product quality in compliance with QMS standards.
2. Leads the organization is implementation of new products.
3. Implements and drives the culture of continuous improvement.
4. Provide guidance to the site for process validation strategies.
5. Manage the preparation, updating in the system of quality documentation, basing the processes on the standard of ISO 13485:2016, ISO 14971 and FDA 21CFR820.
6. Maintain daily communication with the Departments to follow the established QMS processes.
7. Responsible to follow up and ensure that the personnel of the Department under her responsability have the proper training to performance the job duties.
8. Oversee the effective use and further impolementation of eQMS systems.
9. Work with customer and suppliers to develop and approve Quality agreements.
10. Ensures adequate operational quality controls are developed to incorpórate customer and regulatory requirements.
11. Ensure best practices are impolemented and industry standards are applied with QMS applications.
12. Implements the risk based approach to the site QMS and operations.
13. Manage site quality plans for large changes and implementations.
14. Ensure manufactured products are appropriately licensed, produced and marked per local state and federal regulations.
15. Builds and devlops a team of quality and regulatory professionals to support world class medical device manufacturing.

Qualifications

• Bachelor's Degree in a Technical or one of the Life Sciences field.
• Five years or more of experience in equivalent role.
• Excellent oral and written communication
• Strong knowledge in ISO 13485:2016 and 21 CFR 820
• Experience with Regulatory requirements for medical devices is strongly preferred
• Strong management and communication skills
• 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.
• • Broad understanding of manufacturing processes.
• Strong organizational and communication skills.
• Ability to conduct training and present material to a wide range of audiences.
• Problem solving ability through technical knowledge.
• Must be able to influence others at all levels of the organization.
• Must be able to work on personal initiative, have the flexibility to manage change, be able to multi-task and prioritize workload.
• Must be confident in their ability to make decisions balancing business requirements with quality requirements and the associated risks.
• Must possess excellent computer skills, i.e.: Microsoft Office including Excel, Word and Power Point.
• JD Edwards or an ERP system experience is a plus.
• The incumbent must demonstrate and promote teamwork on a consistent basis within the assigned department as well as across functional lines of operations effectively maintaining close communication with all required employees. __

Certification in 13485 desirable.

Additional Information

RRD's current salary range for this role is $80,700 to $129,200 / 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.

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RRD is an Equal Opportunity Employer, including disability/veterans