Senior Quality Manager

This position manages the quality systems and design assurance functions to assure compliance with applicable regulations and corporate requirements. Serve as Management Representative.

Major Areas of Accountability:

Manage the budget, staff, and responsibilities for quality systems and design assurance activities including setting, monitoring and maintaining department goals and individual objectives to assure quality management system effectiveness is maintained. Serve as Management Representative for Coloplast Corp and Coloplast Manufacturing US.
Oversee Quality Engineering support for the R&D organization through active participation on project teams with development of quality deliverables per the project plans and active monitoring of conformance to the design assurance requirements to ensure they meet the intended use and user needs, while assuring quality and reliability
Manage the internal audit program, monitoring compliance to schedules for resulting action items.
Manage CAPA and complaint handling systems, ensuring timely reporting, adequate root cause investigations and compliance to schedule on resulting action items.
Direct the training program for assuring understanding of quality requirements to support compliance with procedures/instructions and applicable regulations, as well as communicating quality management system effectiveness to the organization.
Regularly review and maintain as needed corporate and local procedures/instructions to assure ongoing compliance and appropriateness for local needs
Host or assist with hosting external audits by FDA, ISO notified body quality audits, customers or other appropriate agencies
Manage product reviews, product launch surveillance, and management reviews. Contribute to post-market surveillance and adverse event reporting.
Reviews quality and process performance data against acceptance criteria and provides strategic direction to improve performance and compliance.
Perform complaint processing and analysis, as required
Conforms with Coloplast Q/EHS Policy
Other duties, as assigned.

Essential Qualifications:

Bachelor's degree in an applied technical discipline, engineering preferred
Minimum of 10 years' quality experience in medical device and pharmaceuticals.
Supervisory and administrative experience
Demonstrated knowledge and application of FDA and ISO quality system requirements
Ability to travel up to 20%

Required Knowledge, Skills and Abilities:

Excellent written and oral communication skills
Experience with quality audit systems
Quality engineering principles including design assurance, root cause analysis, sample plans, validation, stability testing, quality plans, change control, and others
Experience leading in FDA inspections and ISO registrar audits