Quality Manager

Join our team as a Quality Manager

Sentec is a Swiss-American medical device company specializing in respiratory care. Since its founding in 1999, the company utilizes deep-tech to develop and manufacture avant-garde technology for complex respiratory patients. Sentec provides healthcare professionals worldwide with non-invasive, accurate monitoring and effective therapeutic solutions.

The Quality Manager is responsible for leading the Quality Department including the oversight of Quality control, inspection acceptance and calibration activities. In this role, you will develop and maintain the Quality Management System, specifically Customer Complains/Feedback, Corrective and Preventative Actions and Non-Conformances.

This position will be located onsite at our Sandpoint, ID facility.

Essential Duties and Responsibilities:

• Establish and maintain effective Quality Assurance functions in compliance with national and international regulations and standards.
• Process and track nonconformities and CAPAs while driving analysis of complaints and other relevant quality processes. Responsible for reporting trends to management.
• Promote continuous improvement by meeting established quality objectives.
• Responsible for preparation, implementation, and follow-up of audits.
• Develop, administer, and maintain quality assurance procedures and activities required to ensure that the company’s processes and products comply with applicable quality standards and regulatory requirements.

Requirements

Qualifications/ Education:

• Bachelor’s degree preferred or equivalent work life experience.
• 5 years minimum in progressive Quality Assurance experience
• Experience in medical device development and manufacturing environment, preferred.
• 2 years minimum supervisory experience required.

Competencies:

• Knowledge of MDSAP, JPAL, China and other international regulations and standards.
• Working knowledge of QSR’s, ISO 13485, MDD, MDR, CMDR, and FDA requirements and standards.
• A working knowledge of quality improvement tools and techniques.
• Strong interpersonal, communication, analytical and complex problem-solving skills, and the ability to develop partnerships & influence.

Physical Requirements:

• This position requires 5 or more hours per day sitting at the computer, talking, and listening, 1-2 hours per day walking and standing. May reach, bend, and kneel. Lifting requirement 10lbs. as needed. Reasonable accommodations to enable individuals with disabilities to perform the essential functions.

Benefits

• Sentec offers competitive benefits like Medical, Dental, Vision, HSA, FSA, and 401K matching, as well as paid parental leave and tuition reimbursement.
• Sentec emphasizes employee voices and recognizes hard work making it a promising environment for professional growth.
• Join a team that fosters collaboration, embraces challenges to strive for continuous learning and improvement.
• Enjoy working in a flat organizational structure that fosters team collaboration and open communication.