Senior Manager, Quality Systems

About the role.

We’re looking for a Senior Manager, Quality Systems who will be responsible for maintaining and improving the Jabra Hearing Quality Management System (QMS) that promotes customer satisfaction and ensures compliance with regulatory agencies and governing bodies (including FDA). Reporting into the General Counsel, they will be involved in all aspects of our QMS: establish/own quality processes and systems compliant to FDA regulations related to the development, distribution and support of our mobile app, the hearing aids we sell, and related accessories; champion continuous improvement efforts to administer an effective QMS; initiate and implement quality improvement activities as appropriate; and educate and train employees as to their involvement in the QMS.

What you’ll do.

• Develop and maintain quality system related procedures according to FDA regulations, including as they are anticipated to evolve; support continuous improvement efforts
• Coordinate and lead QMS audits, plans for Corrective And Preventive Actions related to internal QMS audit findings, and remediate gaps identified in the QMS
• Work collaboratively and liaise with cross-functional stakeholders and parent company quality function
• Design, implement, improve and document procedures for change management, process control, CAPA, process improvement, and document control
• Advise and coordinate regarding 510(k) clearance submissions and impact on the QMS
• Spearhead evaluation & validation of various quality-related systems
• Maintain and manage the risk management analysis (and other supporting documentation) needed to manage change requirements
• Support engineering & development efforts to ensure compliance to procedures and regulatory requirements.
• Implement new or enhanced policies, standards and practices regarding quality as required by regulatory agencies
• Prepare management reports from quality data, including incoming material and overall quality system performance; provide insight and recommendations for improvement
• Prepare and act as lead presenter for Management Review meetings to review the effectiveness of the QMS. 
• Manage any incoming FDA inspections and any resulting Quality Improvement Plans

What you’ll bring.

• Bachelor’s degree or equivalent, preferably in science, engineering or a related field
• Minimum of 5+ years of experience in Quality roles with emphasis on oversight of the QMS in the medical device industry
• Implementation experience and working knowledge of: FDA 21 CFR 803, 806, and 820; ISO 13485; ISO 14971; IEC 62304
• Experience applying QMS processes to the development of software applications
• Experience designing and implementing quality systems maximizing efficiency for business and operations
• Ability to make decisions independently and prioritize multiple projects
• Excellent organizational, leadership, problem-solving, project management, analytical and verbal and written communication skills 

Nice to have.

• Hearing aid industry experience
• Experience with consumer-oriented medical devices with accompanying user apps
• Certification by ASQ (Certified Quality Auditor, CQE, CQM/OE) and/or Lead Auditor Certified to ISO 13485
• EUMDR experience

A sneak peek at our benefits.

• You’re worth it. Our compensation is competitive ($120,000 - $170,000 plus eligibility for an annual performance bonus), and our 401k plan includes matching up to 4%.
• Take care of yourself and your loved ones. We offer excellent medical, vision, and dental insurance, plus basic life and disability insurance, and contribute generously to it. Adding a new member to your family? We also provide 12-weeks paid parental leave.
• Rest and recharge. Whether you check out America’s natural treasures or just relax at home, enjoy your paid time off (employees can accrue up to 20 days of vacation time, approx. 8 days of sick & safe time, and are eligible for 9 company holidays annually). We encourage time off.
• Be well! Jabra Hearing offers a monthly wellness stipend to support you in prioritizing self-care - covering anything from gym memberships and fitness equipment to vitamins and spa visits.