Job Summary:
The Quality Engineer supports product and process design controls through the development and execution of quality plans and continuous improvement. They must be able to identify, implement, and monitor improvements that serve to reduce fallout, rework, and scrap. To develop and maintain process validation plans and protocols. To identify, respond to, and investigate quality issues that impact the ability to meet customer requirements and ensure product safety and efficacy. Drive process improvement change based on quality metrics, tact times, and identified root causes. Participate in preparation and support third party and regulatory audits. Drive product nonconformity disposition.
Essential Duties, Responsibilities and Authorities
Include the following. Other duties may be assigned.
- Lead Corrective Action / Preventive Action (CAPA) initiatives and Quality Issue Investigation (QII) activities.
- React to and mitigate risk associated with the discovery of nonconformance events.
- Provide support to manufacturing engineering while troubleshooting manufacturing methods and issues.
- Perform root cause analysis and develop associated corrective action plans.
- Determine appropriate material disposition for nonconformance events.
- Plan, execute, and oversee inspection of products to verify conformance with specifications and deliverables.
- Identify systemic corrective actions and root causes for both products and processes.
- Provide guidance, leadership, and quality oversight for inspection and assembly, execution of procedures, and general safety.
- Develop and deliver training for continuous improvement efforts and the execution of quality functions,
- Develop and lead validation efforts for processes, equipment, and software.
- Provide audit support for regulatory inspections, customer audits, and 3rd party audits.
- Conduct internal audits in support of maintaining and improving the quality system.
- Support complaint investigations and the implementation of both immediate and longer term corrective actions.
- Develop and implement changes to support continuous improvement.
- Develop and execute Quality Plans for new product and process development. Act as quality representative during new product development process.
- Maintain current industry, regulatory, and QMS expertise.
- Support the development of inspection methods, equipment, and tools.
- Support the development of design and process risk management activities such as inspection.
- Identify, procure, and /or design gauging and equipment necessary for the inspection of machined parts and the assembly of final products and components.
- Process failure mode and effects analysis (pFMEA)
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge of:
Validation concepts (process / equipment / software), root cause analysis, medical device regulations, ISO9001, ISO13485, 21 CFR 820, metrology, SPC, gauge R&R, engineering prints/drawings, statistical sampling.
Familiarity with machining and related processes – turning, drilling, milling, deburring, cleaning, and plating
Skills/Ability to:
Develop and lead validation efforts for processes, equipment, and software. Identify, react to and mitigate risk associated with the discovery of nonconformance events. Develop and implement changes to support continuous improvement.
Acceptable Experience or Training:
- Bachelor’s degree in a science, engineering, or manufacturing technologies related field, or equivalent combination of education and hands on experience.
- 3-5 years quality and manufacturing related experience preferred
- Relevant quality or manufacturing process certification preferred (Lean, Six Sigma, CQE, etc.)
- Experience in a regulated environment preferred (ISO9001, ISO13485, 21 CFR 820, etc.)
- Specific technical training as required
- ISO9001 or ISO13485 lead auditor certification preferred
Certificates, Licenses, Registrations:
A valid driver’s license is needed to enable occasional travel between Western Enterprises facilities.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The typical workday consists of periods of sitting, standing, desk work, hands on inspection of product, and those activities typical of a manufacturing or quality engineer. The work schedule is Monday to Friday, 8:00 AM to 5:00 PM, with occasional overtime required, dependent upon workload and organizational commitments.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The work environment consists of both a typical administrative office area, and a manufacturing shop floor, with some specific areas that require eye and hearing protection.
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