Senior Quality Systems Specialist

Nonin Medical•Minneapolis, MN

2d•Onsite

About The Position

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.

Requirements

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 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

Nice To Haves

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

Responsibilities

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
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
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 problemâ€‘solving methodologies to investigate and resolve quality issues
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
Act as a key liaison between the Quality Systems function and crossâ€‘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