Quality Manager - Vogrinc & Short

Seeking a talented Quality Manager to lead and oversee all quality assurance (QA) and quality control (QC) activities within a leading medical device manufacturer. This person will work closely with cross-functional teams, including R&D, Manufacturing, Regulatory Affairs, and Supply Chain, to maintain a robust quality management system (QMS) and ISO 13485 certification and drive continuous improvement initiatives across the business.

Responsibilities include:

• Lead and manage the Quality team and directly supervise employees. Serve as the primary point of contact for quality-related issues and concerns within the organization.
• Develop and implement the company’s overall quality strategy to align with business goals and regulatory requirements.
• Monitor and report on quality performance metrics, identifying areas for improvement and ensuring corrective actions are taken when needed. Initiate and drive Quality process improvement initiatives, utilizing lean principles, Six Sigma, and other quality tools to enhance product quality and operational efficiency.
• Oversee the development, implementation, and maintenance of the company’s QMS to ensure compliance with regulatory and internal requirements and alignment with global quality standards and regulatory requirements, including ISO 13485, FDA 21 CFR Part 820, etc.
• Ensure the effectiveness and ongoing certification of the QMS (ISO 13485, MDSAP).
• Lead internal and external audits and inspections to ensure compliance with applicable regulations and standards.
• Remain current on the latest developments in medical device regulations, standards, and industry best practices.
• Collaborate with the Regulatory Affairs team to ensure all products meet the necessary regulatory requirements for domestic and international markets.
• Lead the identification, assessment, and mitigation of quality-related risks throughout the product lifecycle. Ensure that all products meet the required specifications, reliability standards, and performance expectations, and all Production and Quality processes are implemented and maintained effectively.
• Collaborate with R&D and Manufacturing teams to support design control activities and ensure products are designed for manufacturability and compliance with quality standards.
• Manage the validation and verification of products and manufacturing processes, ensuring proper documentation and compliance.
• Oversee the management of product non-conformances, CAPAs (Corrective and Preventive Actions), and customer complaints, ensuring timely resolution and documentation.
• Maintain strong relationships with customers, regulatory bodies, suppliers, and external partners to ensure product quality and regulatory compliance.

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degree and/or relevant certifications (ASQ Certified Quality Engineer, Six Sigma Black Belt, etc.) are preferred.
• Proven success in quality management within the medical device industry, including time in a leadership role and in-depth knowledge of ISO 13485, FDA 21 CFR Part 820, MDSAP, and other relevant global quality standards and regulatory requirements.
• Demonstrated record of successfully driving continuous improvement initiatives and delivering measurable results.
• Proficiency in quality management software, document control systems, and data analysis tools as well as familiarity with relevant software applications for record-keeping, scheduling, and reporting.
• Experience with quality risk management tools (e.g., FMEA, Fault Tree Analysis) and product lifecycle management.
• In-depth knowledge of troubleshooting and maintaining electronic devices at company and customer locations.
• Proficient in using diagnostic tools and software for remote support and calibration.
• Strong leadership and people management skills with the ability to influence lead, train, and motivate a diverse team.
• Strong organizational and time management skills, with the ability to manage multiple priorities effectively in a dynamic environment.
• Excellent verbal and written communication skills, with the ability to convey technical information clearly to both technical and non-technical audiences.
• Strong interpersonal skills to build relationships with clients and cross-functional teams. Capable of interacting effectively with senior leadership, regulatory bodies, and external stakeholders.
• Ability to analyze data and reports to identify trends and areas for improvement, particularly in collaboration with Quality and Engineering teams.
• Experience in managing budgets and understanding financial metrics related to service delivery and performance.
• Strong analytical and problem-solving abilities to address technical challenges and customer inquiries efficiently.
• Ability to lift up to 50 pounds
• Willingness to travel as needed to support field operations and customer engagements.

Benefits include:

• Paid Time Off (PTO)
• Paid maternity and paternity leave
• 401(k) with company match
• Comprehensive health, dental, and vision insurance
• Annual bonus eligibility