100 Main St Milwaukee, WI 53201
Job Title: Engineer/ Sales Managers
Location: Milwaukee, WI
Our client, a leading manufacturer of baby products, is seeking a senior Engineer with strong sales and project oversight experience.
This person will oversee product manufacturing engineering and operations as well as the supervision of contract manufacturing partnerships to insure timely delivery, production, quality, compliance, and regulatory guidelines are met.
- Management of Hospital Business contract manufacturing partners.
- Overseeing delivery of required documentation for Hospital Business distribution partners as it relates to quality, engineering, specification, and regulatory requirements.
- Assurance that design documentation and traceability of all design changes are in place
- Successful development, integration, maintenance, and ongoing accountability of the quality management system (QMS).
- Working with management and sales to adapt VOC into design modifications in a timely and efficient manner
- Ensures that validation and qualification activities are consistent with company validation policies and procedures and federal regulations.
- Ensuring that regulatory standards are in place, documented, and continuously updated.
- Overseeing performance and safety testing required ensuring the integrity of the product and brand.
- Overseeing and managing quality and complaint systems with contract manufacturing partners on commercial products with our end-user customers. This would include establishing clear documentation of processes, communication, and seamless delivery and turn-around of product
- Utilizes engineering product development/process knowledge to solve straight forward problems (e.g., FMEA, Process Modeling, Design of Experiments, SPC)
- May provide Quality support for NCMR, Complaints, internal and external audit findings and CAPAs
- B.S. or Higher Degree in Mechanical Engineering
- Certificate in Project Management Preferred
- Must have experience writing master validation plans & writing procedures.
- 10 years or more experience in medical devices
- 7+ years’ experience in operations, quality management, compliance, regulatory, or combination of these are required
- Working knowledge of FDA regulatory requirements for Class II Medical Devices
- Working knowledge of requirements for CE marks and global registrations
- Experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, and ISO 14971) and working knowledge of current and applicable GMP regulations is required
- Process Monitoring Validations, Risk Management, Sampling Plans, Statistics