Director of Quality

Innovia Medical combines the experience and expertise of Summit Medical, Network Medical, DTR and Eagle Labs to help our medical professional partners elevate the delivery of care to improve patient outcomes. We develop products not just for our customers, but with our customers. Our collaborative approach cultivates innovative medical solutions for the global healthcare industry. Through excellence in design, supply chain management, manufacturing and customer service we put Quality at the forefront in all aspects of our business.

Job Summary

The Director of Quality is responsible for managing the Quality Management System (QMS) for Summit Medical and Eagle Labs in compliance with the requirements of ISO13485:2016, 21 CFR Part 820, EU MDD, EU MDR and UK MDR.

Job Purpose

• To ensure the respective QMSs and Quality practices remain compliant with appropriate standards and regulations including but not limited to ISO13485:2016, and 21 CFR Part 820.
• To promote best Quality practice in all areas of the company's operations.
• To support the consistent and continued supply of compliant products on time and in full through effective raw material acceptance, in process quality control, batch release and associated processes.
• To mentor, guide and develop individual members of the Quality department.

Essential Duties and Responsibilities

• Management and improvement of key Quality Systems including but not limited to:

Complaints, CAPA, Non-Conformance, Internal audit program, Design Control, Supplier Quality Management, Product/Process Control and Monitoring, Calibration and Training systems.

• Ownership of customer complaints and quality issues, ensuring effective investigation and resolution to eliminate causes and reduce occurrence.
• Ownership of CAPA system. Leads investigations to determine root cause and corrective actions that will address them directly. Ensure timely closure.
• Management of the internal and external nonconformance process to ensure timely and effective resolution of quality issues.
• Leads internal audits to ISO 13485 and 21 CFR Part 820. Responsible for overseeing the effective completion of the annual internal audit program.
• Provides induction and refresher QMS training and other training on quality systems as required. Together with department heads develops and maintains an effective company-wide training program.
• Leads all audits by customers, Competent Authorities and Notified Bodies.
• Facilitates continual improvement and compliance in relation to all quality practices through ongoing informal review of QMS procedures/practices against ISO 13485 and EU MDR requirements.
• Manages quality-related improvement projects and provides quality support and expertise for wider improvement projects.
• Reports on the status of the QMS to top management.
• Produces and presents annual management review presentations.
• Compiles and monitors quality system and product quality and process capability metrics.
• Establish strategic and tactical plans to drive improved performance to KPI's and goals towards the long-term vision.
• Develop, maintain and review departmental and top level KPIs and recovery plans to meet targets.
• Ensure Quality goals, strategies and tactical objectives are communicated throughout the workforce.
• Use existing and establish new systems to monitor key performance indicators.
• Day-to-day support of production to provide timely, effective resolution of quality related issues.
• Supports the calibration and maintenance system to ensure ongoing compliance.
• Supports Purchasing in supplier approval and ongoing suitability assessment.
• Supports raw material acceptance, in-process control and batch release activity to meet production and delivery schedules.
• Manages Quality team including annual performance reviews.
• Assigns Quality job responsibilities and projects to appropriate employees to support compliance.

This includes, but is not limited to: document control, complaints, CAPAs, training, NMR's, inspection, calibration, supplier approval, supplier audits, deviations, returned merchandise, certificates of compliance, sterilization, sterilization validations, sterile product release, internal audits, management review, product bioburden, dose audits, product monitoring, process monitoring, design activities, cleanroom certification, etc.

• Supports the organizations through the change activities.
• Other duties as assigned.

Additional Regulatory support working closely with the Regulatory Affairs Organization and assisting with:

• Medical device reporting/vigilance, corrections, recalls, removals, safety notices to National Competent Authorities, Notified Bodies and Approved Bodies.
• Product regulatory approvals as and when needed for Market Registrations.
• Maintain FDA device listing and perform annual facility registrations.
• Change notifications (significant) to National Competent Authorities, Notified Bodies and Approved Bodies.
• Maintenance of Certificate of Foreign Government
• Interface with customers to support their registration activities.

Experience & Education Requirements

• Good, all-round knowledge of medical device quality systems with direct experience of ISO 13485:2016, 21 CFR Part 820, EU MDR and UK MDR, ideally with experience of transitioning from EU MDD to MDR.
• A minimum of 10 years' experience in Quality Assurance in a medical devices or similar regulated environment.
• Bachelor's degree or equivalent education in a scientific, engineering, or technical discipline.
• Extensive experience handling deviations and nonconformances, investigations, root cause analysis and corrective/preventive action plans.
• Experienced in leading Quality Assurance Teams across multiple sites.
• Experienced in auditing to ISO 13485:2016, ideally FDA/ISO 13485 auditor training preferred.

Preferred Skills & Abilities

• Strong communication and interpersonal skills including the ability to give feedback
• The ability to make clear decisions in a creative, pragmatic but compliant manner
• Strong investigation, critical evaluation and problem-solving skills.
• Ability to handle multiple tasks with high attention to detail.
• Flexibility and ability to adapt to changing situations
• Ability to train and audit.
• Must take initiative and have a hands-on approach.

We offer a full complement of benefits including health, dental, vision, life insurance, 401(k) and generous PTO. Come work for a growing company that offers a fun, collaborative environment with work-family balance.

This position is on-site at our corporate headquarters in Eagan, MN (near 494/Dodd)

This position is not eligible for a relocation package

Applicants for employment must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status). EOE/Disabled/Veteran