THE OPPORTUNITY
We are currently working with a Butler County based precision manufacturing company to identify a high-energy Quality Engineer to promote quality achievement and performance improvement throughout our client's organization. Our client offers a unique and dynamic working environment based on established core-values of Respect & Dignity, Honesty & Integrity, and Teamwork. This is a direct hire opportunity, offering a competitive base salary and benefits package. The successful candidate will have a critical eye, the love of troubleshooting and resolving quality issues, and a laidback yet dexterous disposition able to navigate various personalities across a diverse customer base. If you meet the below profile, we encourage you to apply and look forward to speaking with you!
POSITION
Responsibilities include:
• Establish product to customer requirements
• Customer deliverables and documentation submissions, including FAIR, quality data packages, CMC-driven change qualification packages.
• Improve the current AS9100, ISO 13485 and ISO 9001 documented Quality-Business System; Develop, implement, and drive changes to bring the Company’s System and Policies into compliance with requirements.
• Work with purchasing staff to establish/communicate quality requirements to external product and service suppliers.
• Ensure the execution of corrective action and compliance with customers’ specifications.
• Monitor performance by gathering relevant data and producing statistical reports.
• Support audit activities including closing out findings, creating reports and determine proper corrective and preventative actions.
• Assist with external failure investigations, aide colleagues as assigned to contain, investigate, identify root cause, and implement action; Analyze trends, as well as corrective and preventive action effectiveness
• Support customer required technical tests and checks.
• Write technical and management systems reports.
• Provide input & recommend improvements to the Company’s quality inspection and product release programs for incoming and in-process materials and components, processes, and finished goods.
• Lead initiatives that aide in the development and implementation of goals, objectives, policies, procedures, and systems pertaining to quality assurance and quality control.
• Maintaining awareness of the business context and company profitability, including budgetary control issues.
• Effectively interact and communicate with multiple departments throughout the company. Support and assist others to meet and exceed department goals.
• Operate with a continuous improvement mindset to proactively identify and act to improve current processes.
• Effectively prioritize and complete assigned tasks, manage multiple projects concurrently and support assigned departmental business processes with minimal direction.
REQUIREMENTS
• Bachelor’s degree and a minimum of 5 years of experience serving as a Quality Engineer; contract manufacturing environment preferred.
• Minimum of 5 years of experience in a heavily customer, client, supplier, and vendor interfacing.
• ASQ Certification preferred; CQE, CQM, etc. will also be given preference.
• Proficient in the use of statistical or analytic software; Minitab preferred.
• Implementation of Six Sigma Methodologies and Lean manufacturing techniques.
• Experience with Capability Studies, A3 Problem Solving, and FMEA.
• Knowledge of ISO 9001, ISO 13485, AS9100 and EN15085 documented Quality Systems; Knowledge of IQ/OQ/PQ documentation.
• Ability to interpret drawing requirements and geometric tolerancing, GD&T, GR&R.
• Must be able to pass a pre-employment criminal background check and drug screen.
