Job Description

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.

RESPONSIBILITIES:

• Plan and implement programs that ensure product quality in compliance with QMS standards.
• Leads the organization is implementation of new products. 
• Implements and drives the culture of continuous improvement.
• Provide guidance to the site for process validation strategies. 
• 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.
• Maintain daily communication with the Departments to follow the established QMS processes.
• Responsible to follow up and ensure that the personnel of the Department under her responsability  have the proper training to performance the job duties.
• Oversee the effective use and further impolementation of eQMS systems.
• Work with customer and suppliers to develop and approve Quality agreements. 
• Ensures adequate operational quality controls are developed to incorprate customer and regulatory requirements.
• Ensure best practices are impolemented and industry standards are applied with QMS applications. 
• Implements the risk based approach to the site QMS and operations. 
• Manage site quality plans for large changes and implementations.
• Ensure manufactured products are appropriately licensed produced and marked per local state and federal regulations.
• Builds and devlops a team of quality and regulatory professionals to support world class medical device manufacturing.

Qualifications :

• Excellent oral and written communication
• Bachelors Degree in a Technical or one of the Life Sciences field.
• Five years or more of experience in equivalent role.
• Strong knowledge in ISO 13485:2016 and 21 CFR 820
• Experience with Regulatory requirements for medical devices
• 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 crossfunctionally 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 multitask 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 :

The national pay range for this role is $68600 to $112900 / year. The pay range may be slightly 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.

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Remote Work :

No

Employment Type :

Fulltime

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