Senior Manager, Quality Assurance

We’re hiring! If you want your contributions to make a real difference, check out this new career opportunity with us at Draeger where we are led by the guiding principle “Technology for Life”.   

The Senior Manager, Quality Assurance is based in our Andover MA office. 

This position will provide strategic direction and tactical, hands-on leadership of the Product Quality Assurance team activities in the DMSI Andover facility.   The candidate will be a hands-on and insightful leader with abilities to drive objectives and programs that maintain product quality, promote compliance, and build strong cross-functional collaboration for new product and post-market product life-cycle management.  This will be supported by ensuring an effective organization through attraction, retention, and development of talent. This position will be enhanced by a leader with business acumen and excellent interpersonal and communication skills.  This will be an audit/inspection facing role. 

Main Responsibilities:

• Responsible for maintenance and continuous improvement of quality system processes and procedures to meet customer expectations and sustain compliance to company procedures, domestic and international regulations, and standards.
• Specifically, support of design and development of new products, product release and manufacturing, and post-market life-cycle management.
• Manage a team of Quality professionals while strengthening the quality organization through attraction, retention, and development of key talent.
• Partner with operations to establish and maintain good manufacturing practices and foster a strong quality culture.
• Lead and participate in cross functional teams to accelerate new product development and drive efficient and effective outcomes from technology transfer, process improvement and general operations initiatives.
• Manage workloads and aggressive timelines, prioritize and work under pressure.
• Participate in cross site communication and information sharing to ensure communication and implementation of industry best practices
• Monitors, evaluates, and manages performance of Quality Assurance Specialists and Engineers on execution of tasks and determines areas for development or corrective action.
• Ensures headcount needs are aligned with organizational demand.  Hires, trains, and develops new members of the Quality organization to ensure effective hiring and onboarding processes are met.
• Responsible for ensuring robust investigations and risk assessment and Health Hazard Assessment of field reported issues to determine whether further escalation is necessary (including product corrective action, field recalls, etc.).
• Drive resolution to internal and external issues via use of effective and compliant quality system processes and communication.
• Assures product quality goals are met by monitoring field failures, complaint trends, and other sources.  Oversee investigation of reported issues and assist with implementation of corrective actions to resolve product quality/process issues.
• Monitor the performance of the Quality System through site quality metrics and determine notifications/escalations, as appropriate to Executive Management
• Performs other duties as needed and assigned.

• BS degree required.  BS in an engineering, medical or scientific discipline preferred. Related education, training and experience will be considered. 
• Minimum of 5-7 years of management experience in medical device/life science functions commensurate with accountabilities described above.
• Significant experience working with regulatory agencies (i.e. FDA) and competent authorities or working directly on regulatory agency documentation and communication.
• Proven record of managing people / working on project teams while working multiple projects.
• Strong influencing skills to lead senior management, peers, and subordinates.
• Ability to work together with others and in a team atmosphere; while displaying civility, cordiality, friendliness, and empathy.
• Ability to travel nationally /internationally, up to 5-10% of the time
• Knowledge of current international and domestic medical product related regulations and standards.
• Demonstrated leadership experience within a product development environment of complex medical products.  Experience with software-based capital equipment products preferred.
• Extensive knowledge and understanding of US, European and International medical device regulations, standards, and guidance documents.

Benefits

Dräger is responsible for life. The lives of our employees are especially important to us, therefore, Dräger believes in fostering a culture that places the focus on employee health & wellbeing, both in the office and at home. We offer a generous benefits package that includes, comprehensive medical, dental & vision coverage, paid time off starting at 4+ weeks per year, tuition reimbursement, 401k match, wellness and employee support programs, life insurance and more. Dräger also offers localized perks such as free parking and onsite gym with fitness instructors and classes, full-service cafeteria, and game room at select locations. 

Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario.

The design, development and manufacturing of Draeger’s Patient Monitoring product line takes place in our Andover, Massachusetts location.

EEO is the Law

Draeger is an Equal Opportunity Employer. To learn more: Know Your Rights: Workplace Discrimination is Illegal (dol.gov)