Senior Quality Engineer (Hatfield, PA) Details

Senior Quality Engineer (Hatfield, PA)

Envista Holdings - Hatfield, PA

Employment Type : Full-Time

KaVo Kerr is a cohesive organization comprised of two global leaders, united to provide dental excellence and serve as a single premier partner for the dental community. KaVo Kerr operates with a common vision inspiring and helping our customers, their patients and our own associates realize their potential. KaVo Kerr offers solutions for endodontics, restoratives, treatment units, infection prevention, imaging, rotary and instruments.

Operating Company:

Job Description:

The Sr. Quality Engineer is responsible for supporting all aspects of the Quality Assurance (QA) program within the Quality Management System (QMS). The position will be working together with Engineering, Production, Purchasing and Sourcing functions to ensure product quality and compliance requirements are met with on-going production. The position will be responsible for the support of the broader organization in continuous quality improvement efforts across Imaging Business Unit, including identification and driving resolutions for Internal/External as well as supplier quality issues (SCARs), CAPAs, monitoring and reporting internal/external PPM (parts per million), and QA support for new product development programs and risk management processes. The ideal candidate will also be responsible for the leadership of process validations (IQ, OQ and PQ) and Material Review Boards (MRBs), and review/approval of supplier data associated with product and specification changes.

PRIMARY DUTIES & RESPONSIBILITIES:

• Participate in site daily management and provide support in resolving quality related issues.
• Support Engineering and Operations in efforts to launch quality improvement programs.
• Lead the implementation of internal and external quality improvement activities (PPM).
• Ensure that the company's products comply with the US Food and Drug Administration (FDA), local and state agencies and the International agencies regulations.
• Execute process improvements as they relate to QMS compliance with ISO/GMP requirements
• Drive Corrective and Preventive Actions (CAPA) related to product/process improvements.
• Work closely with Technical Support and Sales team to improve customer relationships and customer service.
• Write, execute, and review Process Validation Protocols and Reports (IQ, OQ, PQ).
• Utilize Supplier Corrective Action Request (SCAR) process to improve and sustain supplier quality.
• Perform Internal audits and participate in Supplier and 3rd Party Audits.
• Routinely compile and report quality Key Performance Indicators (KPIs) key quality metrics data to multiple organizational levels.
• Support Risk Assessment (DFMEA, PFMEA) and Engineering Change Order (ECO) processes.
• Lead routine Material Review Board (MRB) meetings to identify supplier quality issues and ensure timely disposition of nonconforming materials.
• Serve as lead resource for Production Part Approval Process (PPAP).

Job Requirements:

The Sr. Quality Engineer must have excellent problem solving and presentation skills, learns a new environment quickly. The Sr. Quality Engineer must have the charisma and credibility to communicate and influence change at all levels within the organization. This role will identify, communicate and implement the key priorities to the organization with little guidance or direction and exercising judgment to determine sense of urgency for priority. The Sr. Quality Engineer will continuously demonstrate strong Envista values. This role will foster cross-functional problem solving and cooperation.

REQUIREMENTS:

• Bachelor’s Degree in Engineering or related fields required.
• 5+ years of experience in progressive Quality Assurance role, exposure to FDA regulations / ISO 13485 requirements is required.
• Experience with statistical software packages (E.g. Minitab), as well as Microsoft Office tools.

• Sense of urgency : Action-oriented and able to recognize problems and opportunities. Communication : Effectively communicate to all levels within the organization and influence change outside of the local span of control.
• Customer Focus: A drive to discover and meet the needs of customers (either internal or external) Results Oriented: A drive to achieve results and goals in the short and long term. Adaptable to Change: The ability to adapt in an environment of change, uncertainty, and ambiguity. Can pragmatically make decisions in a timely fashion, especially when there is not a clear path.
• Analytical : Conducts comprehensive review of quality issues and complaints.
• Leadership : Supervises large team of associates, with commitment to identifying and developing talent. Ability to influence others : Must be able to inform, convince, and persuade others to action on key initiatives.

PREFERRED QUALIFICATIONS:

• Experience with Root Cause analysis, Statistical Techniques, Lean Manufacturing, and Six Sigma preferred.
• Experience and working knowledge of electrical medical device manufacturing preferred.
• Experience with SAP helpful, but not required. Experience with MDSAP requirements and EU MDD/MDR regulations is preferred.

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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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.