Quality Engineer - Mativ
Orangeburg, NY Not Available
About the Job
Description
responsibilities:
- Ensure thorough and timely investigation of product and process non-conformances and customer complaints, investigating the root cause, and then ensuring effective and appropriate corrective and preventative action is implemented.
- Capture, trend and use Quality metric data and control plans to monitor manufacturing process performance
- Use appropriate six sigma and other QE tools to facilitate Quality improvement, as required
- Participate and provide input into the pFMEA process, supporting as part of the pFMEA team
- Partner with cross-functional teams to ensure effective process validation, change management and process control
- Identify continuous improvement initiatives in Production and Quality processes, taking action to ensure implementation of effective change
- Troubleshoot Quality issues on the Production floor using an analytical approach and data analysis to draw conclusions and work with Production personnel towards a successful resolution
- Champion the processes required to maintain a state of audit readiness within Production areas
- Maintain and improve Production documentation for example Device History Records, Quality Plans and Device Master Records
- Assist in developing and implementing Quality Management System processes: aid in preparing and implementing QMS documentation
qualifications:
Required
- Bachelor’s degree in science or engineering (or equivalent)
- At least 5+ years of experience working within a Quality Engineering role, preferably gained within the medical device and / or pharmaceutical industry
- Good understanding of ISO 13485 and FDA 21 CFR 820
Preferred
- Knowledge of ISO 14971 standard
- Lean Six Sigma Green Belt Certification
- Certified Lead Auditor qualification
Competencies
- Detail-orientated, excellent organization skills and diligent
- Proficiency in Microsoft Office software (e.g. Word, Excel, PowerPoint, Outlook etc.)
- Experience with computer-based Quality data information systems (e.g. Minitab, ERP systems etc.)
- Excellent problem solving and analytical skills using formal process tools and techniques
- Excellent verbal and written communication skills
- Strong interpersonal skills, works collaboratively within and across teams
What we offer
As a Mativ employee, you’ll have access to a variety of benefit programs designed to help you no matter your stage of life.
- Medical, dental and vision insurance
- Consumer-Driven Health Plan (CDHP)
- Preferred Provider Organization (PPO)
- Exclusive Provider Organization (EPO)
- Company-paid basic life insurance and Additional voluntary life coverage
- Paid vacation and competitive personal time off
- 401(k) savings plan with company match
- Employee assistance programs – available 24/7 to you and your family
- Wellness and Work Life Support - career development and educational assistance
ABOUT MATIV
Mativ Holdings, Inc. is a global leader in specialty materials headquartered in Alpharetta, Georgia. The company makes material impacts on the world every day through a wide range of critical components and engineered solutions that solve our customers’ most complex challenges. We manufacture on three continents and generate sales in nearly 100 countries through our family of business-to-business and consumer product brands. The company’s two segments, Filtration & Advanced Materials and Sustainable & Adhesive Solutions, target premium applications across diversified and growing end-markets, from filtration to healthcare to sustainable packaging and more. Our broad portfolio of technologies combines polymers, fibers, and resins to optimize the performance of our customers’ products across multiple stages of the value chain. Our leading positions are a testament to our best-in-class global manufacturing, supply chain, and materials science capabilities. We drive innovation and enhance performance, finding potential in the impossible.
Mativ and its subsidiaries are Equal Opportunity Employers. Qualified applicants
Source : Mativ