Senior Quality Systems Specialist

Senior Quality Systems Specialist

NONIN MEDICAL INC - 3.3

Minneapolis, MN Job Details 5 hours ago Benefits Paid parental leave Health savings account Paid holidays Disability insurance Health insurance Dental insurance Tuition reimbursement Paid time off Parental leave Vision insurance 401(k) matching Life insurance Qualifications Quality control corrective actions Regulatory inspections Statistics Record keeping Microsoft Excel Microsoft Outlook Audit report preparation ISO standards 5 years Engineering Regulatory compliance Compliance audits & assessments Corrective and preventive actions (CAPA) GMP Compliance management implementation Customer inquiry handling Master's degree Quality assurance audits Policy & process development Bachelor's degree in engineering Bachelor's degree Continuous improvement Certified Quality Auditor Data interpretation Overseeing audit functions Senior level Training Document management Cross-functional collaboration Communication skills Cross-functional communication FDA regulations Full Job Description 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 Quality Management System Ownership Ensure the effective deployment, maintenance, and ongoing performance of a compliant Quality Management System (QMS) Support the development, implementation, and continuous improvement of processes and procedures in alignment with regulatory requirements Drive efficient, compliant quality processes across the organization Process Ownership & Compliance Serve as the process owner for assigned QMS areas, including Audits, CAPA, Document Control, and Training Ensure assigned processes meet FDA, ISO, MDR, and applicable regulatory expectations Support Device Master Record (DMR) and Design History File (DHF)-related activities Data Analysis & Continuous Improvement Analyze and interpret QMS performance data to identify trends, risks, inefficiencies, and improvement opportunities Prepare detailed reports and present findings, insights, and recommendations to management Apply structured, systematic problem‑solving methodologies to investigate and resolve quality issues Audit & Inspection Readiness Prepare for and actively support external regulatory audits and inspections Ensure readiness of documentation, processes, and records Collaborate with internal stakeholders to support responses to audit observations and findings Cross‑Functional Collaboration & Guidance Act as a key liaison between the Quality Systems function and cross‑functional teams to ensure alignment with business objectives and regulatory requirements Provide guidance to project teams on quality planning, risk assessments, and process validations Support quality training initiatives and promote understanding of QMS requirements throughout the organization

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.