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Senior Quality Engineer - Racine, United States - O&H Danish Bakery
Description
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:
Responsible for Nonin Medical manufacturing product quality and regulatory compliance.
Define and implement quality processes that will result in production operations compliance to specifications, GMP and ISO Provide support to Manufacturing, Warehouse, Logistics, and Post Market Quality in addition to partnering with Supplier Quality and New Product Development teams.
Ensure delivery of quality product to the customer by taking the appropriate measures to ensure work instructions are accurate, maintain visibility to process variability, maintain clear acceptance criteria, and reduce quality risk such that manufacturing operates in a consistence state of process control.
Essential Job Functions:
Provide Quality Assurance support to support to manufacturing, sustaining engineering, and warehousing operations
Implement process improvements that result in predictable process performance across all manufacturing product lines
Responsible for process variability and risk reduction, scrap reduction, and post market quality investigations
Support supplier quality corrective action and cost reduction initiatives
Ensure all process variables and their interactions are adequately defined in addition to verifying that all process failure modes have been identified and addressed via the use of DOE studies, FMEA's etc.
Drive correction and permanent corrective action issue resolutionImplement methods to inspect, test and evaluate the reliability of manufacturing processes, products and production equipment
Ensure processes meet cGMP's, ISO 13485, and all other design, regulatory, and quality requirements
Serve as a quality advocate, providing quality requirements and controls training and mentoring to the organization
Provide functional expertise to other support functions on quality related issues
Implement statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling plans)
Provide work direction to Quality Technicians and QC Inspectors
Approve product and process change requests in compliance with business policies and procedures
Analyze customer complaints, conduct product failure analysis, determine root cause, and implement corrective action
Conduct risk analysis including Health Hazard Assessments as required
Define process and product validation requirements, prepare and approve Master Validation Plans, protocols and reports
Disposition product suspected as being non-conforming and review performance trends to determine the effectiveness of corrective action
Support regulatory agency and customer quality audits and CAR's
Develop product quality plans, project protocols in documents, and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members
Completes Nonconformance Exceptions and CAPA including identification, disposition of affected product, investigation and corrective actions for manufacturing, quality systems, audits, and complaints nonconformances
Develop Process Monitoring Systems at critical process steps to identify process variation. Conduct data analysis using Six Sigma tools to assist in the reduction of defects
Lead permanent corrective action Quality Improvement Project teams. Use formal project management tools including project charters, A3's, and Gantt charts to communicate project status, track execution, and promote employee accountability
Partner with the Operational Excellence, Sustaining Engineering, and R&D teams to ideate and implement cost reduction improvements. Together, deliver year-over-year reduction in the cost of manufacturing goods
Assign auditing teams to verify compliance to training, GMP, and adherence to manufacturing processes
Required Qualifications:
B.S. degree in Electrical or Mechanical Engineering or a related field
Minimum 5 years Quality Engineering experience in the Medical Device industry or a similarly highly regulated field
Working knowledge of FDA 21 CRF part 820, ISO 13485, MDD/MDR regulations
Strong data analysis skills
Experience using statistical software such as Minitab, or similar
Demonstrated success applying Lean/Six Sigma methodologies
Experience with Complaint Handling processes and Complaint investigations
Strong Process Validation, Risk Management, CAPA expertise
Must be self-directed and possess the ability to manage competing objectives
Excellent written and verbal communication skills
Demonstrated ability to work with cross functional teams in a highly dynamic work environment
Strong project management and organizational skills
Proficiency in Microsoft Office (Word, Excel, Outlook)
Preferred Qualifications:
Green or Black Belt Six Sigma certification
Lean Certification
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.
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