- Manage validation program – IQ,OQ, PQ, & Gage R&Rs.
- Support projects related to lean manufacturing plant layout, process to ensure efficient and timely completion.
- Assist with design transfer to manufacturing, including quality control activities from production processes to shipment of the final product.
- Work with Contract Manufacturer (CM) to review existing process and implement new manufacturing processes.
- Inspect product including labeling and documentation for release of finished goods.
- Manage product traceability and labeling.
- Manage and maintain product device history records.
- Ensure that all production employees are familiar with, trained on, and follow all manufacturing procedures related to their jobs Ensure that changes to procedures are reviewed, approved and validated prior to implementation.
- Oversee creation and review of documentation for nonconforming product.
- Lead product investigation related to customer complaints and corrective actions.
- Works with Engineering department ensuring that engineering change orders affecting production related changes are reviewed.
- Assist with revisions and updates to quality procedures, standardized work instructions.
- Maintain equipment calibration program to ensure equipment is calibrated in a timely manner.
- Participate in supplier management activities. Identify supplier issues.
- Assist with APQP and Risk Management Documentation.
- Support Internal Quality Audit.
- Support 3rd party audit and inspection activities.
- Coordinate and Support Weekly Inspection of Facilities, Daily Facility Walks and Bioburden & Particulate Assessment.
- Identify, Communicate, Drive & Support Resolution of Quality Issues as Identified in the Production Area.
- Support Sterility Management Program.
- Support Document Control & Lab Functions.
- Champion cGMP – General Omnsbudman for Production.
- BS degree in manufacturing, mechanical, industrial or process engineering, highly desired
- Minimum of 2 years' experience (5+ years preferred) in manufacturing engineering in a process driven manufacturing environment
- Hands-on experience troubleshooting equipment
- Proficient with SolidWorks or equivalent 3D CAD software
- Working knowledge of Microsoft Office products (Work, Excel, Outlook, PowerPoint)
- Ability to multi-task and meet deadlines in a fast-paced environment
- Ability to communicate effectively and professionally with internal and external parties
- Ability to work in a team environment
- Standing on concrete floors for several hours at a time.
- Essential physical requirements, such as climbing, standing, stooping or typing.
- Lifting up to 30 pounds.
- Work in loud/chaotic environments.
- Wear appropriate PPE such as mask, goggles, footwear as applicable.
- The ability to see and respond to situations.
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Quality Engineer - Hudson, United States - H.B. Fuller
Description
As the largest pureplay adhesives company in the world, H.B. Fuller's (NYSE: FUL) innovative, functional coatings, adhesives and sealants enhance the quality, safety and performance of products people use every day. Founded in 1887, with 2023 revenue of $3.5 billion, our mission to Connect What Matters is brought to life by more than 7,000 global team members who collaborate with customers across more than 30 market segments in over 140 countries to develop highly specified solutions that enable customers to bring world-changing innovations to their end markets.
H.B. Fuller acquired Adhezion Biomedical, LLC which is a medical device company engaged in the development, manufacturing and commercialization of highly-differentiated, proprietary, cyanoacrylate-based adhesive and infection prevention products.
Quality Engineer that will work with our Operational quality team. This individual will own all quality activities for their assigned product lines and may be working on multiple different products lines at once. They will be assigned to products for new product development and work closely with internal team and Contract Manufacturer on each product. Support Design Engineering and Manufacturing Operations by developing manufacturing processes, work instructions, fixtures, and production equipment.
This individual will be reporting to the Quality Manager for HHC Hygiene Global.
Primary Responsibilities:
Minimum Requirements:
Physical Environment and Requirements:
Pay is based on several factors including but not limited to education, work experience, certifications, and geographic location.
The salary for this role is $85, ,000.In addition to your salary, H.B. Fuller offers employees a competitive total rewards package including comprehensive benefits, incentive and recognitions programs, health & wellness benefits, 401K contributions, paid time off and paid holidays. Eligibility may vary.