Medella Life is currently working with a phenomenal leader in contract manufacturing who specialise in medical device tubing and catheter components. It is an exciting time for the company as they are in the process of expanding their quality department in California and are seeking a Quality Engineer II to join them!
The role
Perform Quality Assurance/Quality Engineering activities to ensure components, finished products, and processes meet established specifications. Analyze materials and processes, make recommendations, or take action to correct deficiencies. Support the Quality Policy, ensuring that customer, regulatory, and quality system requirements are met or exceeded.
Responsibilities
- Develop Control Plans, Inspection Instructions, and other documents as needed to effectively manage product and process quality, both internally and at the suppliers.
- Develop and review documented operating procedures associated with material inspection or processes.
- Support Engineers to develop manufacturing in?process inspections.
- Perform In?process, incoming, and final inspections.
- Conduct and Review inspections onto tubing extrusions.
- Participate in the review and approval of Document Change Notice.
- Collect, analyze, and interpret statistical data.
- Assist in Design of Experiments and Statistical Process Control to improve processes and products.
- Assist suppliers in developing inspection methods.
- Perform Gage R&R and correlation studies.
- Provide support towards Internal/External Quality System Audits.
- Provide training and assistance to inspectors, technicians, and other Engineers.
- Work with QA Technicians and Engineers to resolve issues.
- Participate in the Material Review Board of nonconforming materials to evaluate and disposition material, and to assign corrective actions and perform effectiveness review of actions taken as necessary
- Work with Engineers on new inspections, and cross?train other QA technicians
- Design tools and fixtures to support Quality Engineering activities.
- Other duties and responsibilities may be assigned, depending on company needs.
Requirements
- Bachelors of Science in Engineering or equivalent degree.
- 2 years of experience as an Engineer, preferred in the medical device industry.
- Quality Engineering capacity or equivalent work experience. Internships and co?ops will be considered.
- Familiar with FDA regulations and Engineering Standards, ISO 13485 familiarity preferable.
- Experience in Root Cause Analysis Methodology
- Ability to read and interpret engineering drawings and GD&T symbols.
- Ability to create 3D models and detail drawings in SolidWorks or equivalent CAD tool.
- Knowledge and understanding of medical devices especially catheters.
- Knowledge of Good Manufacturing Practice (GMP)
- Excellent problem solving and trouble shooting skills
- Excellent verbal and written communication skills are required.
- Ability to work in a fast?paced contract manufacturing environment.
- Ability to work on a multiple project simultaneously.
- Must be comfortable with MS Office Package, Minitab, and other software used for work.
- Candidate must be results oriented, quick learner, respond to the urgent needs of the team.
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything.