Location : Saddle River NJ US 07458
Job Type : Temp/Contract to Direct
Reference Code : 19470-BZ1
Compensation : open - 45-55/h
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Engineering
Job Description :
- Contract to direct position for a Manufacturing Engineer with test method validation and six sigma experience for medical and/or pharmaceutical manufacturing.
- Lead, plan, write, and execute validations (i.e. equipment, process, and test method) in a dynamic, early start-up medical device environment that requires a hands-on approach.
- Support and help manage the quality assurance and quality control functions both on-site and at suppliers by planning and executing activities concerned with the development, application, training and maintenance of quality standards for processes, materials and products.
- Working with the product development engineering function for identified products.
- Lead continual improvement efforts by analyzing workflow, processes, improve efficiency, reduce waste, improve part quality, improve yield, and maintain safety.
- Prepare and implement quality control plans and procedures according to company policies, industry and international standards working closely with the engineering and operations groups to identify and implement quality control requirements.
- Develop and oversee the IQ, OQ, PQ, and test method validation efforts and implement all quality system requirements to support product development and manufacturing efforts.
- Develop and initiate standards and methods for inspection, testing, and evaluation utilizing knowledge in inspection and manufacturing fields.
- Coordinate and support first article inspection and validation activities.
- Disposition NCMRs and lead CAPA investigations.
- Participate in risk analysis activities at different phases of product development, product, and commercialization.
- Determine and implement systems, controls and procedures to ensure an efficient and quality compliant manufacturing function.
Required Qualifications :
- BS Engineering, Chemical Engineering preferred
- Experience with Medical device/Pharmaceutical, cGMP, QSR and ISO training.
- Lean Six Sigma trained.
- Minimum 5 years experience as manufacturing or quality engineer for medical device manufacturing.
- Minimum 5 years experience in equipment, process, and test method validations in medical device manufacturing.
- Minimum 3 years experience in clean room manufacturing of medical devices, chemicals, or pharmaceuticals.
- Experience drafting and executing validation and verification protocols for medical device quality systems.
- Hands on experience within a manufacturing environment with machine set-up, production, troubleshooting, and process improvement tasks.
- Proficiency in MS Office (i.e. Word, Excel, PowerPoint, and Visio).
- Ability to read blueprints.
Contact: Bill Zukowsky