Position Summary:

The Quality Manager of Bemis Health Care is a hands-on position that will provide leadership, oversight, and direction, quality management and product quality for injection molding and assembly in Bemis Health Care (BHC). Serves as the BHC Management Representative and ensures the quality system is effectively established and maintained in order to meet ISO 13485 and FDA and other regulatory requirements.

Supervisor Responsibilities:

Recruit, interview, hire, and train new staff in the department.
Mentor and guide direct reports.
Oversee the daily workflow of the direct reports.

Specific Responsibilities:

Responsible for the day-to-day operations of BHC Quality in supporting customer and operational needs.
Responsible for filing necessary applications and handling all interactions pertaining to the regulation process for products requiring clearance and registration.
Supports process validation team by developing protocols, statistical analysis, and PQ reports including software validation activities.
Lead the corrective actions to improve customer satisfaction.
Maintain post-market surveillance reports annually.
Report adverse events to the appropriate internal and external regulatory authorities as needed.
Maintain Quality Metrics and coordinates data collection and analysis for Management Review including semi-annual quality data summary reports.
Act as the Quality representative on product development team responsible for design control requirements and design changes including developing procedures to ensure regulatory compliance.
Develop and implement methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed utilizing and promoting statistics.
Lead customer/notified body and internal audits.
Responsibility for Risk Management Process.
Review and approve device labeling content and marketing material.
Review/update all QA/MFG/other documents as Author.
Collaborate with supplier representatives on quality problems, ensure that effective corrective actions are implemented and contributes to supplier quality improvement programs.
Review of customer surveys and contracts for management approval.

Skills & Qualifications:

Bachelor's degree in quality, engineering, or management discipline.
7-9 years of quality experience in a medical device manufacturing environment operating under certified quality management system (ISO 13485).
Minimum of 3-5 years of experience in a leadership role.
Knowledge of FDA and international device regulations.
Certification or experience as lead auditor (ISO 13485 or 9001).
Strong problem solving and analytical skills as well as the ability to multi-task.
Strong communication and demonstrated ability to work effectively with cross-functional work groups including suppliers, customers, and associates, both verbally and in writing.
Ability to present information and respond to questions from managers, sales, and customers.
Strong computer skills with in-depth knowledge of Microsoft Office required.
Experience with other quality software applications beneficial. (e.g. statistical analysis).
Proactive with ability to make sound decisions and take action.
Experience in plastics and plastic processes is beneficial.

Travel expected at 10-15% Bemis Manufacturing Company does not offer employment-based sponsorship for work authorization, including H-1B, TN, or any other visa status. 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