Quality Engineer - Fixed Term Contract

Job Summary

In this role, you will support all quality system and functions. Assists in establishing systems to support the facility to drive continuous improvements and minimize the costs of non-conformance. Plans, schedules, executes and communicates all items regarding quality issues, complaints, validations and other projects to the QA Manager and/or other interested parties. Performs all duties associated with compliance-related items for ISO standards and cGMP.

Essential Duties and Responsibilities

• Support site Quality Engineers/Quality Specialists in meeting customer expectations in complaint investigation responses.
• Aid in assuring expected turn-around time metric is attained.
• Assist in developing site Quality Engineer staff in usage of tools and processes for customer complaint investigations/continuous improvement.
• Analyze data, process capabilities, customer concerns and expectations and any other leading or lagging indicators which may be used to improve product and process knowledge.
• Interact with customers to understand and integrate those requirements into West manufacturing and quality system requirements.
• Identify manufacturing and development constraints.
• Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence.
• Assists facility with quality improvement programs by utilizing Six Sigma tools and Lean techniques, including the education of facility personnel on these tools and techniques.
• Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in-process SPC programs.
• Participates in ISO and corporate quality system audits.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Other duties as assigned.

Education

Bachelor's Degree in Engineering or Business required

Work Experience

• 3+ years of experience in a Quality engineering role at an engineering, pharmaceutical, or medical device manufacturer required
• 3+ years of experience in the use of computer-based measuring equipment (e.g., Coordinate Measuring Machine) required
• Experience in conventional toolroom machinery (mills, lathes, surfaces grinders) preferred

Preferred Knowledge, Skills and Abilities

• Knowledge of ISO 9001, cGMP
• Proficiency in all Microsoft Office applications.
• Flexibility in providing support beyond normal working hours when necessary.
• Awareness of all relevant SOPs/SOIs as per Company policy as they are related to the position covered by this job description.
• Always comply with the Company's Safety and Quality Policies
• Trained Quality Auditor.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Formal apprenticeship or training in an engineering background.
• Knowledge of SPC
• Knowledge of "Lean Manufacturing" techniques.
• Knowledge and experience in all processes involved in the manufacture of rubber compression molds.
• Qualified Lead Auditor.
• Formal qualification in Quality Management

License and Certifications

• Manufacturing\Six Sigma Green Belt Certification Upon Hire preferred
• Manufacturing\Lean Six Sigma Black Belt with DOE experience Upon Hire preferred

Travel Requirements

10%: Up to 26 business days per year

Physical Requirements

Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.

Additional Requirements

• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve and prioritize.
• Self-motivated with the ability to make independent and sound judgments.
• Read and interpret data, information, and documents
• Learn and apply new information or skills