Please submit resumes to Navjot Singh - [nsingh(at)divihn(dot)com].
Description - Quality Engineer
we have 2 Openings (Level I and II)
Top 3 must haves -
Medical device manufacturing experience, preferably with implantables. Previous experience in a Quality role within either manufacturing or design. Knowledge of FDA and EU medical device requirements.
Top Technical skills needed -
Statistical analysis skills, Corrective and preventive action investigation experience, able to read and interpret drawings.
Will they need to enter cleanroom? Yes, they need to be able to be trained and physically able to enter the cleanroom. The candidate must be comfortable with the cleanroom environment and be willing to remove makeup in order to enter the cleanroom.
Any overtime, if yes how many hours: No OT planned.
Provide Quality Engineering support to manufacturing teams for tissue products. Lead quality improvement projects and participate in quality activities as assigned. Provide support for released products, evaluating and trending complaints. Lead and/or support key development and continuous engineering projects. Lead investigations into nonconformances and CAPAs.
Essential Duties and Responsibilities -
- Provide quality engineering support to manufacturing lines, including floor support, non-conforming product investigations, change order control requests reviews, and new equipment qualifications.
- Perform return product investigations for product complaints.
- Own key deliverables in support of development and continuous/sustaining engineering R&D projects, which may include: first articles, mold tool qualifications, component qualifications, shelf life validations, and sterilization validations.
- Work with manufacturing and R&D engineers to prepare manufacturing work instructions, material specifications, and inspection documentation. Set inspection requirements, set inspection methods and inspection sampling plans.
- Support quality control inspectors with new product inspections and quality issues that arise during inspections.
- Provide leadership for nonconformance investigations and CAPAs and assigned.
- Support internal audits and supplier audits.
- Self-motivated worker, persistent, curious
- Strong communication skills
- Working knowledge and understanding of mechanical drawings
- Strong problem solving, technical writing, and statistical analysis skills
- Preferred experience with supporting a manufacturing product line
- Preferred experience with tissue products
- Desired experience with sterilization processes.
Education and/or Experience -
- B.S. degree in Engineering or Science (Biomedical Engineer, Chemical Engineer, Chemistry, Biochemistry, Materials Science)
- 3+ years in an engineering role within a Medical Device company. Must have working experience of GMP and ISO 13485 requirements.
Physical Demands -
- Sitting/standing 8 hours per day. Light lifting may be required on occasion.
- Ability to work using a microscope
- Ability to be in a clean room environment with varying humidity levels
Working Environment -
Ability to travel occasionally.
Engineer I: to support daily manufacturing quality work with things like non-conformance investigation, problems on the floor talking to operators, assisting with projects that require some statistical tools (repeatability and reliability study), assisting with Design of Experience. This person will assist one of the Senior Engineers on the team.
Strong Chemistry/Biology background – Chemical/Biomedical Engineer/Chemist. They are very chemical-dependent processes (no Electrical Engineers)
The individual shouldn’t hesitate to ask questions; the individual some leadership potential (this person should take charge of the project once they take on it) and work with minimal hand-holding. Self-starter.
R&D Experience is a bonus
Experience – Entry level
Educational Qualifications – Degree + Internships / Degree + 1 to 2 years / pure internships acceptable / degree and someone with some demonstrated experience/someone pursuing a Bachelors (graduating within a year) is OK
Medical Device Industry Experience – preferred, but not a must
Engineer II: This is an Engineer I with experience. Support manufacturing floor; handling projects and be able to lead small projects and have work experience.
Experience – ideally 3 years of experience
Medical Device Industry Experience – Must
Educational Qualifications – Degree (Science related) with demonstrated 2 to 3 years of experience
R&D Experience is a bonus
Non-Local Candidates OK? Local Candidates ONLY
Start Date – ASAP
Job Type: Contract
Salary: $25.00 to $30.00 /hour
- Quality Engineer: 1 year (Preferred)