Our client located in Franklin, Ma is looking for a Quality Engineer to join their team on a direct hire basis.
The qualified candidate should be able to use Quality & Process Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision.
- The individual must be capable of working independently and in a team setting supporting the Quality and Operations groups.
- Investigate and resolve work-in-process problems to reduce/eliminate scrap and rework
- Analyze process statistics and conduct efficiency studies
- Recommend and implement process improvements and modifications
- Establish production/process standards
- Supports on-site transfer projects and product scale-up activities.
- Optimizes manufacturing processes to provide sustainable gains in cost effectiveness and product performance through statistical analysis, designed experiments, and procedural changes.
- Drive quality improvements by increasing internal competencies in process control / verification and validation studies, root cause analysis, failure mode and effects analysis (FMEA), and the use of Process Excellence tools.
- Works with suppliers, customers and participates in multi-functional teams to resolve technical/quality issues and develop new protocols.
- Partner with Operations to assure alignment of goals, objectives and strategies.
- Provide general engineering support to in-process inspection & in-coming inspection.
- Implement quality and efficiency improvements in in-process inspection.
- Evaluates process critical quality parameters and updates specifications and protocols.
- Additional duties and responsibilities as required.
Level of Skill, Education and Experience:
- A minimum B.S. in an engineering discipline preferably mechanical engineering.
- 0-5 years experience.
- Strong engineering skills, problem analysis/solving.
- Excellent written and oral communication skills. Understanding of GMP, FDA and SOP standards, guidelines, and regulatory requirements.
- Ability to work in a fast paced manufacturing environment while managing multiple projects.
Strong engineering skills with working knowledge of the following:
- Process validation and verification activities. (IQ, OQ, PQ, PPQ).
- Risk analysis techniques, which include PFMEA (Process Failure Modes and Effects Analysis). Manufacturing Control Plans and Flow Plans.
- Blue print & GD&T reading. Problem solving techniques including root cause analysis, and cause and effect analysis.
- Proficiency with Microsoft Office products (Word, Excel, Project, PowerPoint) and Minitab.
- Experience in the Medical device is highly desired. Hands-on experience in the manufacturing, quality & process disciplines.