Senior Manager, Quality Systems



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Job Type




Salary Range

Based on Experience

No. of Openings


Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435 Phone : 612-630-1200



Job Description


The Senior Manager, Quality System supports the implementation of the Quality Management System. This position will lead continuous improvement projects within the QMS to improve efficiency and effectiveness, participate in audits across all areas of the business and the supply chain, and provide Quality Management System training to employees.


* Subject Matter Expert (SME) for the QMS

* Support the analysis and future QMS needs of the organization, including integration/harmonization of QMS across multiple sites. Assesses the impact of proposed changes to the Quality Management System.

* Process Champion for CAPA, Deviation/Nonconformance, Complaint, Change Control, Audit, and Document/Record systems.

* Regularly compiles and reports on Quality Metrics and Objectives to monitor department and site performance.

* Supervise, lead, and mentor Quality System team, including staff responsible for complaint handling and investigation, document management, change management, and other QMS support activities.

* Execute and support QMS audit activities, including internal, client, due diligence, and regulatory. Facilitate and lead response activities resulting from audits. Participates in supplier audits, as needed.

* Author and collaborate on new or revised documents affecting the Quality Management System. Evaluate compliance of QMS documentation, including identification and remediation of system gaps.

* Provide training on the Quality Management Systems, including current Good Manufacturing Practices (cGMP) and critical QMS subsystems.

* Support implementation of software for GxP systems, including contributing to configuration requirements, test and validation execution, and development of procedures/work instructions.

* Perform duties in accordance with the Company's Quality Systems and with standard operating procedures (SOPs) that are consistent with regulatory requirements and industry standards


* Bachelor's degree in Engineering, or another equivalent technical field

* Achievement of an advanced degree in engineering, science, or quality is a plus

* Minimum of 5 years' experience leading a diverse group of employees

* Minimum of 8 years' experience in the development, configuration, and maintenance of Quality Management Systems, specifically related to medical devices or combination products.

* Knowledge of GMP, ISO, QSR, and other applicable international regulations, standards, Directives, and Guidance

* Ability to train and educate stakeholders, partners, and management on QMS

* Ability to manage and lead multiple tasks and projects

* Experience as a key contributor on continuous improvement projects

* Experience interfacing with internal customers, partners, and suppliers

* Strong ability to define problems, organize and collect date, establish facts, and draw valid conclusions

* Customer service-oriented attitude and ability to exercise sound business judgement