Overview

Nonin Overview: You can count on Nonin. Our vision is to improve people’s lives by creating noninvasive medical devices people can count on, even in challenging conditions. Nonin’s culture is grounded in our mission and vision, and our values are reflected in our commitment to diversity, equity, and inclusion. Diversity, Equity, and Inclusion are more than words to us, they are our DNA. We aspire to advance our medical technology for the global diverse patients, customers and communities we serve. We embrace the unique backgrounds, perspectives and mindsets of our employees, and seek to enhance these qualities through our hiring and talent management strategies. Our employees are empowered to bring their full authentic selves to work and collaborate to build a more rewarding environment for all to work and thrive. With a career at Nonin, you can expect to work in an environment where diversity is celebrated and curiosity is rewarded. By joining Nonin, you will improve lives around the world, including your own.

Job Overview: Responsible for providing quality oversight and direction to supplier and inspection activities, policies, and processes ensuring all materials used in the manufacture and customer delivery of Nonin products, meet the design, quality and value mission in accordance with corporate objectives and customer requirements

Responsibilities

What you will do:

• Develop, execute and monitor Supplier Quality activities, policies, processes and procedures are focused on the highest standards of quality, continual improvement and customer satisfaction
• Establish and implement effective supplier selection, qualification and approval mechanisms for use by Nonin Medical. Conduct supplier audits and maintain supplier quality records
• Develop, execute and monitor incoming inspection plans, sampling methods and test methods to ensure component and product conformance to requirements
• Establish robust measures for supplier quality performance, monitor results regularly and initiate appropriate actions to continually improve supplier quality performance
• Provide Supplier Quality Engineering technical support for receiving inspection department
• Aggressively and proactively ensure the rapid response and successful resolution of supplier quality issues in order to minimize or eliminate potential business interruption.
• Ensure compliance with all applicable regulatory requirements
• Provide input as a materials review board (MRB) member and be the primary conduit to resolve all supplier non conformances.
• Compile operational quality metrics for presentation at QMR meetings to trend, recommend, and implement corrective actions and appropriate follow-up, when necessary.

Qualifications

Required Education and Experience:

• Bachelor’s Degree in Engineering, Biotechnology, Computer Science Engineering Technology or equivalent technical Degree; or equivalent combination of education and experience.
• 1-5 years Quality Assurance experience or equivalent. Experience with Supplier Quality preferred

Required Knowledge, Skills, & Abilities:

• Knowledge of FDA QSR requirements.
• Knowledge of ISO and other recognized international quality system standards.
• Knowledge of world class quality techniques and implementation.
• Demonstrated ability and knowledge of inspection techniques and requirements.
• Demonstrated ability to work in a highly regulated environment.
• Good communicator with the ability to influence and persuade across all levels of the organization as well as with suppliers and customers, exercising a high degree of tact and diplomacy to accomplish objectives.
• Good interpersonal, project management and presentation skills, with the ability to clearly present recommendations and ideas and to summarize complex issues.
• Ability to work well under pressure in a fast-paced, time-sensitive environment with shifting priorities and multiple deadlines.
• Self-Starter; Highly Organized; Complex Problem-Solving; Strong Analytical Judgment; Technical Detail-Oriented; Administrative
• High Standard of Integrity & Ethics; Customer-Focused, Creative & Innovative; Positive Attitude; Aggressive in the pursuit of goals; Results-Driven; Action-Oriented, Flexible & Adaptable
• Ability to independently determine and develop an approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives.

Preferred Qualifications:

• Prior Supplier Quality experience
• Experience with FMEA, DOE, SPC and related statistical tools.
• Experience with electronic components, PCB assemblies, injection molded parts, mechanical assemblies, medical products.
• Lean manufacturing and continual process improvement experience.

Physical Requirements:

• 5-10% domestic & international travel
• Ability to sit, stand, and/or walk for 8 hrs/day.
• Ability to examine assemblies and subassemblies using a microscope
• Occasional need to lift and/or move up to 50 pounds with aid of pallet jack

Benefits:

• 401(k) & 401(k) matching
• Medical, Dental & Vision insurance, including flexible spending and health savings accounts
• Profit sharing
• Disability insurance
• Accident & Critical Illness Insurance
• Employee assistance program
• Life insurance
• Paid time off
• Parental leave
• Bereavement leave
• Employee referral program
• Tuition reimbursement

Nonin is an Equal Opportunity/Affirmative Action employer committed to creating a diverse workforce. We consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identity, disability or veteran status, among other factors.