As a Senior Quality Engineer, you will provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Additionally, you will support supplier quality issues impacting daily operations; advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers; ensure compliance to regulation and standards. This role will also focus on new product launch and sustainment support for Integrated Manufacturing business unit in Kalamazoo, MI.
- Support execution and analysis of manufacturing related complaints and product field actions.
- Disposition non-conforming product within MRB, issuing NC’s as appropriate.
- Support the development and review of process and equipment validation/qualification and MSA of internal processes.
- Engage in the development and improvement of the internal manufacturing processes for existing products.
- Support and Drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
- Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes.
- Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
- Participates and may lead in the creation and/or review of new or modified procedures.
- Applies statistical methods of analysis and process control to current operations.
- Performs critical assessment of internal and supplier proposed change management activities.
- Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.
- Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes.
- Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.
- Collaborates with Divisional QA, cross-functional and suppliers’ teams to address top quality issues.
- Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
- Performs PPAP activities for supplier changes
- Support the creation and maintenance of inspection methods and sampling.
- Work closely with operations and the business functions to ensure quality performance of product and processes.
- Engage and interface in internal and external audits providing subject matter expertise
- Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure.
- Support improvement projects or new product launch activities by working with cross-functional team
- Own identified internal and supplier driven non-conformances and manage the timely closure of NC’s within Trackwise.
- Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.
Qualification & Experience:
- Strong in critical thinking and “outside the box” thinking.
- Ability to represent Quality function with project teams.
- Bachelor’s Degree in Engineering
- Familiar with GD&T (Geometric Dimensioning and Tolerancing)
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated ability to work independently and as part of cross-functional teams.
- Familiar with metrology (i.e. calipers, micrometers, pin gages, CMM (coordinate measuring machine), etc.)
- Strong interpersonal skills, written, oral communication and negotiations skills.
- Machining background/experience is a plus (lathe, mills, etc.)
- MS, CQE, or CRE preferred.
- Familiarity with ISO 13485, GDP, GMP desired.
- Experience in interacting with regulatory agencies (FDA, TUV, etc.) desired.
- Six Sigma Green or Black belt preferred.
- Understanding of US and International Medical Device Regulations.
- Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
- 2+ years of experience
- Highly developed problem-solving skills. Strong analytical skills.
- Previous medical device industry experience desired.
- Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
- Previous experience using CAD Software
Vacancy Type: Full Time
Job Location: Kalamazoo, MI, US
Application Deadline: N/A