Manager, Operational Quality

NONIN MEDICAL INC; Minneapolis (MN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

401(k) Match

Life Insurance

Incentive Plans

Medical, Dental, Vision

Flexible Work Schedules

Paid Time Off

Job summary

Nonin Medical in Minnesota seeks a senior Quality Engineering leader to sustain and advance regulatory compliance for medical devices, including FDA QSR, ISO 13485, and EU MDR/MDD.

You will lead Quality Engineering teams across product, manufacturing, and supplier quality, drive post-market strategies, and partner with executive leadership to strengthen the company’s quality culture and business objectives.

Qualifications

• 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.
• 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 work effectively under pressure in a fast-paced, time-sensitive environment with shifting priorities and multiple deadlines.

Responsibilities

• Ensure operations comply with applicable regulatory standard requirements including FDA QSR and ISO 13485 requirements.
• 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 obsolescence/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.

Skills

Regulatory knowledge

Leadership

Communication skills

Problem solving

Attention to detail

Education

Bachelor's Degree in Engineering or related technical discipline

Job description

You can count on Nonin. Our vision is to improve people's lives by creating noninvasive medical devices people can count on. Nonin's culture is grounded in our mission, and we live by our cultural tenets of courage, ownership, and agility. The courage to challenge assumptions and take risks, the ownership to act with accountability, and the agility to constantly innovate and move with speed. It is these tenants that have made Nonin the technology leader for over 40 years. As a privately owned company, you are not one among many, but an important part of our success with the ability to learn, grow and impact all aspects of the business. We embrace the unique backgrounds, perspectives, and mindsets of our employees and collaborate to build a more rewarding environment for all to work, thrive and have a little fun. So, if you are looking for a smaller company to spread your wings while making big company impacts, join Nonin today... Together we will improve lives around the world, including your own.

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.

Physical Requirements:

• Sit, and/or stand for 8 hrs/day.
• Bend/stoop/kneel 1-2 hours/day

Nonin Medicalis an Equal Opportunity/Affirmative Action Employer - Disabled/Veteran. To request a copy of our Aff

It is the policy of Nonin Medical that all offers of employment made shall be contingent upon successful completion of electronic background check(s). These checks will be job-related, consistent with business necessity, and conducted by our vendor pursuant to all applicable laws, rules, policies, and procedures of our candidates' specific locale.

Equal Opportunity Employer
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