We are looking for a Quality Engineer to join our client in Franklin, Ma on a direct hire baiss.
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 of the company.
Primary Responsibilities (Essential Functions):
- The individual must be capable of working independently and in a team setting supporting the Quality and operations groups. Major responsibilities include:
- 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
- Implement real-time Statistical Process Control
- Support on-site transfer projects and product scale-up activities.
- Optimize 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 effect analysis (FMEA) and Process Excellence tools.
- Work 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 & incoming 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 with 0-5 years of 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.
- Supplier quality experience highly desired.
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, Blueprint & 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 medical device is highly desired.
- Hands-on experience in the manufacturing, quality and process disciplines.