Senior Quality Systems Specialist

Company Overview

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 40 years. As a privately owned company, each of us operate with a shared commitment. 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. Recognizing that each one of us is unique, we build flexibility and choice into our philosophies. 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 make big company impacts, join Nonin today… Together we will improve lives around the world, including your own.

Key Responsibilities

Required Education & Experience:

• Bachelor’s degree in Engineering, Science, Manufacturing, or related field
• 5+ years of experience in Quality Systems, Quality Compliance, or Auditing within a highly regulated environment (Medical Device, Pharma, or Aerospace); or equivalent combination of education and experience

Knowledge, Skills, & Abilities:

• Knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971:2019 (Risk Management) requirements, Medical Device Regulation (MDR) requirements, and Current Good Manufacturing Practices (cGMP)
• Excellent interpersonal and communication skills
• Experience in Quality System compliance and managing audits.
• Ability to write reports, audit responses, and procedures.
• Ability to respond internally to common inquiries from customers, regulatory agencies, or members of the business community.
• Proficiency with Microsoft Office products, including Excel, Word, PowerPoint, and Outlook
• Good analytical and statistical problem-solving skills/tools

Preferred Qualifications:

• Master’s degree
• Experience in project management
• Knowledge of medical device requirements in Brazil, Canada, Australia, or other worldwide regulations
• ISO 13485 Certified Lead Auditor or CQA
• Experience with IEC 62304 Software Lifecycle requirements

Physical Requirements:

• Sit, and/or stand 8 hours/day

Benefits:

• Financial Security: 401(k), Employer Match, Tuition Reimbursement, Competitive Salary and Benefits Package
• Health and Wellness: Medical, Dental & Vision coverage, Flexible Spending and Health Savings Accounts, Telemedicine Options, Mental Health and Fitness Offerings
• Flexibility: Paid Time Off and Paid Holidays, Paid Parental Leave
• Personal Protection: Disability Insurance, Accident & Critical Illness Insurance, Life Insurance

Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Disabled/Veteran. To request a copy of our Affirmative Action policy, or if a disability prevents you from applying for a job online, call us at 1-800-356-8874 and ask for a human resources representative.

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.