Bachelor's Degree in Engineering or related field, or equivalent experience
7+ years in medical device technical service/support or quality/compliance
3+ years of supervisory/leadership experience
Proven track record in achieving organizational business objectives
Familiar with FDA QSR, ISO 13485, and EU regulations
Strong communication skills with regulatory agencies
Ability to manage pressure and shifting priorities
Responsibilities
Ensure compliance with FDA QSR and ISO 13485 standards
Implement quality processes for production and complaint analysis
Lead operational quality engineering processes including complaint handling and manufacturing validation
Manage Quality Engineering teams to meet quality and business goals
Drive post-market quality and regulatory compliance initiatives
Develop post-market strategies to support business objectives
Facilitate audits and inspections by regulatory agencies
Benefits
401(k) Match and Incentive Plans
Comprehensive Medical, Dental, and Vision coverage
Flexible work schedules and Paid Time Off
Life Insurance options
Voluntary benefits tailored to individual needs
Full Job Description
Benefits of being a Nonin Team Member.
Financial Security: 401(k) Match, Life Insurance, and Incentive Plans
Health and Wellness: Medical, Dental, Vision, and Voluntary Benefits to meet individual needs
Flexibility: Flexible Work Schedules and Paid Time Off
Key Responsibilities:
Ensure operations comply with applicable regulatory standard requirements including FDA QSR and ISO 13485 requirements.
Implement industry-standard quality processes to support and enable production, supplier and complaint-analysis processes.
Direct and enable compliant, efficient and risk-based execution of operational quality engineering processes including complaint handling and analysis, manufacturing process validation, design transfer, sustaining/continuation engineering, post-market surveillance, storage/preservation of product, non-conforming product, supplier quality, receiving and first article inspection, and environmental/materials compliance.
Lead and manage Quality Engineering (Product, Manufacturing, Supplier) teams to support achievement of operational quality and overall business objectives.
Lead and drive downstream post-market quality/regulatory compliance and tasks in support of departmental objectives and overall corporate business objectives including vigilance reporting, medical device reporting, non-reporting determinations, complaint handling, HHE, field action/recall, sales order control, PMS/PSUR, trade compliance, GUDID/EUDAMED, product obsolesce/end-of-life and facility registrations/device listings.
Develop and implement technical service support and post-market strategies to support achievement of organizational business objectives.
Drive operational quality process improvements and updates using continuous improvement approach.
Develop and grow high-performing team to support operational quality activities; facilitate organizational cohesiveness and cross-functional cooperation within the Nonin operating model, business strategy and culture of quality and compliance.
Support efforts for QMS remediation activities, if necessary.
Participate in project teams to provide operational quality leadership and input
Collaborate with executive management in determining departmental organizational plan, operating model, strategy deployment, and governance procedures.
Facilitate and manage inspections and audits by applicable regulatory agencies including FDA and EU notified body.
Manage and oversee the development and delivery of technical training and product education related to domestic and international customers and distributors.
Required Education & Experience:
Bachelor's Degree in Engineering or related technical discipline, and/or equivalent experience.
7+ years progressive experience in medical device technical service/support, quality/compliance or similar experience in regulated life sciences industry.
3+ years of supervisory/leadership experience.
Demonstrated history of successful technical service, quality and/or compliance organizational leadership and successful achievement of organizational business objectives.
Knowledge of applicable regulations in the areas of the FDA QSR, ISO 13485 and EU MDR/MDD.
Strong written and verbal communication skills, especially when dealing with regulatory agencies or certification bodies
Ability to explain and resolve differences in the interpretation of standards, regulations and quality system requirements.
Ability to work effectively under pressure in a fast-paced, time-sensitive environment with shifting priorities and multiple deadlines.
