Quality Control Engineer

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.
Position Overview: The Quality Control Engineer is responsible for developing and advocating for quality processes, practices and principles. This quality leader will drive compliance to regulatory requirements including cGMP, ISO13485, and UL standards in addition to manufacturing processes, customer requirements, and safety and environmental regulations. Lead internal quality audits and serve as a key participant in regulatory and customer audits, supplier management reviews, quality improvement teams, and post market quality reviews. Partner with both Quality and Manufacturing engineers to reduce process variability, develop and deploy employee training, and implement permanent corrective action. Provide work direction to Quality Control inspectors and ensure that the manufactured product meets all requirements. Test and assess Quality Control systems to make sure that a company's practices conform to both internal and external standards. Develop Quality Control performance reports and monitor corrective action effectiveness.
Essential Job Functions:

• Serve as the lead GMP continuous improvement champion for Operational Quality and the manufacturing execution partner for the Quality Management System lead
• Verify the implementation and effectiveness of the processes and procedures that support the Quality Management System
• Ensure processes meet cGMP's, ISO 13485, and all other design, regulatory, and quality requirements
• Partner with manufacturing engineering to develop improvement ideas for manufacturing procedures, equipment, test methods, tooling, and fixtures that ensure compliance to manufacturing specifications and Quality Controls
• Drive "First Time Quality" in manufacturing and in the warehouse
• Serve as the Project Manager for quality improvement initiatives
• Train employees on Operational Excellence and company policies while leading process certification
• Track and support the completion of all action items resulting from internal and external performance audits
• Evaluate adherence to work instruction, calibration, preventative maintenance, and shop floor paperwork. Maintain employee training records, shop floor paperwork, and other quality documentation records. Ensure on-time completion, record clarity and document storage per procedure
• Manage Quality Control inspections and conduct periodic compliance auditing.
• Develop and improve manufacturing and warehouse policies, processes, and standards
• Partner with other leaders to deliver training, improve systems, and clarify work direction
• Provide NCMR, CAPA, and LMS training to all employees and drive permanent corrective action to eliminate quality issues
• Ensure the effectiveness and compliance to regulatory and operational quality policies such as labeling, nonconforming product identification, quarantine, and data analysis
• Understand, interpret, and apply quality principles and processes in compliance with QMS, corporate, and other rules and regulations
• Monitor calibration and equipment/tooling maintenance dates to ensure all required calibration and maintenance occur per timeline with no past due performance Provide Quality improvement training and guidance to engineering on GMP, SOPs, forms, validation protocols, and reports
• Provide supervision to Quality Control inspectors. Participate with peers in the formulation of overall direction, processes, systems and talent development for the Quality department and company quality culture
• Create a culture of inclusion while embedding DEI principles.

Required Knowledge, Skills & Abilities:

• Bachelor's degree in Electrical or Mechanical Engineering or a similarly related degree
• 5 years medical device experience with audit experience
• In-depth knowledge of Quality Management System (QMS), cGMP, ISO 13485, with the ability maintain awareness of updates to industry standards
• Prior experience supporting Quality Control, production and/or warehouse teams
• Strong data analysis skills, proficiency in root cause analysis, and expertise driving permanent corrective action analysis
• Results driven leader with the ability to work under pressure in a fast-paced, dynamic environment
• Must be continuous improvement focused with the ability to effectively lead, mentor, and drive positive change
• Strong project management, problem solving, data presentation, and organizational skills
• Ability to write technical reports, business correspondence, and administrative procedures.
• Experience using statistical software such as Minitab, or similar
• Demonstrated success applying Lean/Six Sigma methodologies
• Strong understanding of Process Validation, Risk Management, CAPA
• Excellent written and verbal communication skills
• Strong project management and organizational skills
• Proficiency in Microsoft Office (Word, Advanced Excel, Outlook)

Preferred Qualifications:

• ASQ certified quality auditor and/or ASQ certified quality engineer (CQE)
• Six Sigma Black Belt certification
• Lean Manufacturing certification
• 2 years' experience developing and deploying training material
• UL certification experience
• 3 years or more as a Quality auditor

Physical Requirements:

• Ability to frequently sit, stand, walk, reach with hands and arm's length, climb or balance, stoop, kneel, and crouch
• Ability to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally life and/or move up to 50 pounds

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.