Quality Manager - Fixed Term Contract

Quality Systems Manager

This is a Fixed Term Contract Opportunity Expected to Last Approximately 1 Year with the Ability to Be Extended.

Position Overview :

This function is responsible for the management and oversight of the Quality Systems. Responsible for developing, identifying, analyzing, and improving the quality system. This process will follow the Convatec Quality Management Systems, as well as applicable regulations and standards (e.g., 21 CFR Part 820, ISO13485, Japan MO-169, Brazil ANVISA).

Key Responsibilities :

• Supervise the Quality Systems Team and Their Support to All Product Categories.
• Assist and Coach the Teams in Conducting Investigations of Trainings, Document Activities, Complaints, Non-Conformities and / or Corrective Preventive Actions.
• Oversee the Complaint System, Assuring Corresponding Evaluations and / or Investigations Are Completed in a Timely Manner, Trends Are Analyzed, and Applicable Actions Are Executed (e.g., CAPAs, SS, HHE).
• Report Progress of Investigations for Complaints, Non-Conformities, Preventive / Corrective Actions, Internal / External Audits, Stop Shipments, HHEs and Any Other Applicable Quality System Requirement.
• Oversee the CAPA System, Assuring Corresponding Investigations, Corrections, Containment, and Corrective / Preventive Actions Are Taken, as Well as Insuring That Their Effectiveness Is Measured; This While Also Maintaining a System That Complies with QMS Requirements.
• Oversee the Training and Document Management System, Assuring Corresponding Activities, Trainings, Evaluations and / or Investigations Are Completed in a Timely Manner, Trends Are Analyzed, and Applicable Actions Are Executed.
• Execute / Report / Analyze Trend Analysis Related to the Quality Management System.
• Participate in Local and / or Corporate Meetings Representing the Site Quality System and Communicating Any Action / Activities That Are Needed.
• Oversee / Prepare Corresponding Reports and / or Meeting (e.g., Trend Analysis, Management Reviews) to Assure the Quality System Is Robust and Complies with Requirements, and, If Applicable Raise Corresponding Action to Keep in Compliance.
• Manage the Quality Audit Process. Oversee / Prepare the Schedule and Coordination of Both Internal Audits and External Audits. Conduct Audits and Support Auditors. Conduct Audits According to the Program and Communicate Their Results. Report Non-Conformities Found During Audits. Prepare and Submit Audit Reports.
• Lead External Audits and Certification Program.
• Support and Participate in Company Projects.
• Identify, Develop, and Implement Continuous Improvement Projects for Products and Processes.
• Carry Out, Together with Your Team and If Required, CAPA (Corrective and Preventive Actions).
• Follow and Enforce the Corresponding Policies and Procedures, Implementing Solutions Aligned to the Needs of the Business and Its Products.

Authority (If Applicable) :

This Role as Signatory Rights as Listed on Quality Management Systems Records and Procedures.

Skills & Experience :

Qualifications / Education :

Dimensions : Team :

Quality Systems Leads and Applicable Personnel.

Principal Contacts & Purpose of Contact :

Travel Requirements :

You Will Be Expected to Travel an Estimated 30% of the Time, Mainly to Different Convatec Plants (Depending on Business Requirements).

Languages :

Working Conditions :

Special Factors :

Ready to Join Us?

At Convatec, We're Pioneering Trusted Medical Solutions to Improve the Lives We Touch. If You're Ready to Make a Real Impact, Apply Today and Help Us Bring Our Forever Caring Promise to Life.

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Equal Opportunities

Convatec Provides Equal Employment Opportunities for All Current Employees and Applicants for Employment. This Policy Means That No One Will Be Discriminated Against Because of Race, Religion, Creed, Color, National Origin, Nationality, Citizenship, Ancestry, Sex, Age, Marital Status, Physical or Mental Disability, Affectional or Sexual Orientation, Gender Identity, Military or Veteran Status, Genetic Predisposing Characteristics or Any Other Basis Prohibited by Law.

Notice to Agency and Search Firm Representatives

Convatec Is Not Accepting Unsolicited Resumes from Agencies and / or Search Firms for This Job Posting. Resumes Submitted to Any Convatec Employee by a Third Party Agency and / or Search Firm Without a Valid Written and Signed Search Agreement, Will Become the Sole Property of Convatec. No Fee Will Be Paid If a Candidate Is Hired for This Position as a Result of an Unsolicited