Senior Quality Engineer
Greene Group Industries
Port Huron
Overview
We are seeking a highly motivated and detail-oriented Senior Quality Engineer to lead our quality assurance initiatives within a dynamic manufacturing environment. This pivotal role involves developing, implementing, and maintaining robust quality systems that ensure our products meet the highest standards of safety, efficacy, and compliance. As a senior member of the quality team, you will drive continuous improvement efforts, oversee quality audits, and ensure adherence to industry regulations such as ISO 13485. Your expertise will help shape our quality culture and support our commitment to delivering exceptional products to our customers.
Duties
- Provide direct, on-the-floor support to manufacturing operations.
- Analyze production data and identify areas for improvement in real-time to optimize manufacturing processes and minimize downtime.
- Utilize ANSI sampling, AQL, problem solving techniques to determine product acceptance, evaluate process capabilities CPK and determine product and continuous improvement plans.
- Generate internal quality documentation such as advance process quality planning APQP, SOPs and work instructions and submitting First article inspection report FAIR/ production planning approval process for customer approval.
- Review nonconforming materials for disposition, participate in and / or lead quality review meetings.
- Perform part inspections on metrology equipment such as calipers, micrometers, gauge pins, and Keyence for dimensional inspection to meet product specification.
- Work with Engineering to review designs for measurement fixtures and plans for new product launches.
- Ability to be active part of Investigations, support the team by following up on CAPAs status and be a guidance to the business partners.
- Analyze performance reports and process control statistics; investigate and analyze relevant variables affecting products and processes.
- Perform and analyze Gage R&R and measurement systems analyses.
- Support GGI’s quality management system auditing activities and compliance of Quality Management Systems. Participate in internal audits and Fresh Eyes Audits for the Greene Group Business Units.
Requirements
- Bachelor's Degree or higher in a technical field.
- 10 years' experience in a quality engineering role within a manufacturing setting, preferably in regulated industries such as medical devices.
- Experience with ISO 13485: 2016 / 9001:2015 been involved in audits and part of CAPAs.
- Demonstrated expertise in conducting quality audits and implementing effective QA/QC processes.
- Excellent analytical skills with the ability to interpret complex data sets and identify root causes.
- Experience in developing and managing quality systems, documentation control, and compliance programs.
- Proficiency in project management tools and methodologies to lead continuous improvement initiatives.
- Knowledge of Lean Manufacturing concepts, principles, and philosophies (i.e. – Lean, Six Sigma, Statistical Process Control, and Failure Mode & Effects Analysis).
- Excellent communication skills, both verbal and written in the English language.
- Ability to interact effectively and professionally with co-workers and outside contacts, including customers and suppliers.
