Director, Quality and Compliance

Job Responsibilities

• Oversee aspects of the quality system including, but not limited to, change control, supplier quality, records management, equipment and process validation, training and competency program and documentation, internal and external audits, risk management, CAPA, data review, and management review.
• Facilitate the development and update of corporate quality objectives.
• Manage and coordinate with Regulatory for the successful maintenance of ISO 13485 and MDSAP certification including other country requirements as necessary.
• Assist departments throughout the company to identify, document, and implement quality system procedures, including work instructions and forms that ensure compliance to worldwide regulatory requirements (as applicable), as well as guidance documents, standards and common specifications where devices are being marketed. Schedule and lead regular management reviews per procedural requirements.
• Proactively coordinate, collaborate, and communicate with management and teams internally and with our customers and suppliers to resolve problems/complaints and execute projects in a timely and effective manner.
• Communicate key quality scorecard metrics and provide routine management reporting and coordinated corrective and preventive action (CAPA) plans to address areas of deficiencies.
• For significant product issues, coordinate the assessment of the issue, Health Hazard Evaluation, field action, field safety notice, and/or recall efforts, as appropriate.
• Ensure training, as related to quality systems, procedures, and operator certification is effective and completed.
• Ensure organizational capability to support ongoing product development and sustaining engineering programs along with manufacturing support for incoming inspection, product quality, and non-conforming material analysis.
• Maintain a culture of high attention to quality in all aspects of product development and manufacturing.
• Perform miscellaneous duties as assigned by management.

Qualifications

• College degree in engineering, science, medicine or equivalent.
• History of completing Quality System Audit Programs and/or experience in Quality System auditing.
• 10-15 years of experience and in-depth background in quality systems at least 5-8 years of which are in medical devices.
• In depth experience with QMSR/GMP/ISO and applicable international standards and regulations as required by specific country market requirements experience.
• Solid grasp of medical terminology.
• Excellent communication, leadership, and organizational skills.
• Ability to adapt and change as needed in a growth-stage company environment.
• Onsite presence working at our Brooklyn Park, MN headquarters at least 4 days per week is required.