Senior Quality Assurance Specialist
2 months ago
Senior Quality Assurance Specialist
Job SummaryThe Senior Quality Assurance Specialist leads the determination of non-conformance and customer complaints through containment, root cause, corrective action, and audits. They ensure product compliance to customer specifications and industry standards.
Key Responsibilities- Lead development, deployment, and oversight of metrics for the Quality Management System (QMS) at the site to ensure appropriate monitoring of the health and compliance of the processes.
- Ensure products comply with customer specifications, industry standards, regulatory requirements, and Plexus standards. Ensure Assembly Build Instructions (ABIs) comply with specifications and standards. Approve all changes and deviations from established guidance, including Engineering Change Orders (ECOs).
- Lead creation and maintenance of the Master Validation Plans, when required, and ensure compliance. Support creation and execution of documents for validation. Serve as the Plexus lead to support external customer audits and internal audit activities.
- Support recertification and surveillance of Quality Management System (QMS) audits. Lead product-related Corrective and Preventive Action (CAPA) discussion and closure.
- Ensure continuous quality compliance during manufacturing operations. Monitor ongoing manufacturing operations to ensure quality issues are quickly addressed; provide quality alerts and lead containment and purges, when required.
- Lead the development of the inspection strategy for receiving inspection, pre-ship inspection, and out-of-box-audits. Ensure Certificates of Compliance are created and maintained, including documentation of deviations.
- Ensure creation and maintenance of manufacturing quality history documentation, as required.
- Build and embed Quality Awareness in Operations by ensuring effectiveness of training and inspections. Educate operators and production associations on quality and compliance procedures.
- Typically requires a Bachelor's degree and a minimum of 2 years of related experience; or equivalent work experience.
- A combination of education, experience, and time in field will be taken into consideration, and internal candidates may have distinct requirements tailored to their demonstrated skills and contributions within the organization.
- Ability to work well in a fast-paced manufacturing environment.
- Strong ability to identify and solve problems proactively using structured problem-solving tools, including making timely and effective decisions.
- Apply systemic data analysis and problem-solving to address a full range of technical and organizational problems with creativity, imagination, confidence, and responsibility.
- Ability to design and conduct experiments, as well as to analyze, interpret, validate, and communicate data to key stakeholders.
- Ability to seek out best practices and apply them within their assigned area.
- Ability to design a system or process to meet desired needs within realistic constraints such as economic, efficiency, repeatability, environmental, health, and safety. Includes documentation and controls to ensure long-term sustainability.
- Ability to become a Subject Matter Expert for an assigned system or process.
- Ability to coach and mentor technicians and other support staff within assigned areas of expertise.
- Ability to operate effectively in a cross-functional team environment.
- Ability to effectively lead projects involving cross-functional team members.
Role will support operational teams in a manufacturing environment with required personal protective equipment. Facilities include comfortable temperatures, repetitive low noise level, and suitable lighting for required tasks. May require walking, standing, and sitting, using a computer, and other office equipment. Direct interaction with people and equipment is event-driven and will include activities related to inspecting, qualifying, troubleshooting, and improving jigs, fixtures, and manufacturing methods using different types of components or material. Role may require working individually on tasks with a prolonged focus on written material, working collectively as part of a team of various disciplines and backgrounds, and working in multiple software systems.
Travel RequirementsLess than 40%
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