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Kavo Quality Engineer II (Hatfield, PA)

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Quality and Regulatory Affairs
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Kavo Kerr
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1016 Total Views

JOB SUMMARY:

The Quality Engineer II will be responsible for several Quality Engineering functions within the Imaging business.  Supporting daily Operations needs and identifying and driving the resolution of internal quality issues. Supplier Quality management by identifying and driving the resolution of product quality issues. This will be done through process and hardware verification/validation, supplier quality initiatives, leadership of Material Review Board meetings, and systemic improvements to the Quality Management System (QMS).  This position will also be responsible for the review/approval of supplier data associated with product and specification changes.

 

PRIMARY DUTIES & RESPONSIBILITIES:

  • Identify and drive the resolution of internal quality issues.
  • Utilize Corrective Action/Preventive Action (CAPA) process to improve and sustain quality improvements to the QMS and/or product.
  • Utilize Supplier Corrective Action Request (SCAR) process to improve and sustain supplier quality.
  • Perform/participate in Supplier, Internal, and 3rd Party Audits.
  • Writing, execution, and review of Validation Protocols and Reports.
  • Routinely compile and report key quality metrics data to multiple organizational levels.
  • Lead routine Material Review Board (MRB) meetings to identify supplier quality issues and ensure timely disposition of nonconforming materials.
  • Participate in site daily management and provide support in resolving quality related issues
  • Ensure that the company's products comply with the US Food and Drug Administration.
  • (FDA), local and state agencies and the International agencies regulations.
  • Performs other duties and task as assigned by supervisor/manager.

REQUIREMENTS:

  • Associates degree plus 4 years of medical device manufacturing related experience.
  • Bachelor's degree in Mechanical, Manufacturing or Electrical Engineering or similar Science discipline or background.
  • 3-5 years of Quality Assurance experience within an FDA/ISO 13485 regulated industry.

 

PREFERRED QUALIFICATIONS:

  • Working knowledge of Process Controls and Design Controls within a regulated Quality Management System (CFR 820).
  • Applicable knowledge of Risk Management and Supplier Quality management is required.
  • Experience in working within an ISO/FDA compliant Quality Management System.
  • Understanding of EU MDR desired, but not required.
  • Experience with root cause analysis, statistical technique, lean manufacturing, trending, Risk Management, and Six Sigma methodologies.
  • Past experience in Operations highly desired.
  • Internal/Supplier auditing experience helpful, but not required.
  • Experience with SAP helpful, but not required.
  • Excellent problem solving and presentation skills, as well as the ability to quickly learn a new environment.
  • Cross functional experience with products, engineering processes and manufacturing processes to maintain credibility to communicate and influence change at all levels within the organization.
 
Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
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About Envista

Envista is a global family of three companies and more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists’ clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including KaVo Kerr, Nobel Biocare Systems, and Ormco, partner with dental professionals to help them deliver the best possible patient care.


Envista separated from Danaher as an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.

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For more than 100 years, KaVo and Kerr have been serving the needs of dental professionals. As industry leaders, and with rich expertise and product development, we continue to improve our clinical products and services to support dental professionals in the best diagnosis and treatment of their patients.

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Built on over 60 years of continuous innovation, Nobel Biocare Systems is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications.

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Ormco has a distinguished 50+ year history of providing the orthodontic profession with high quality, innovative products backed by attentive customer service and educational support.

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