Manufacturing Supervisor - Injection Molding
Manufacturing Supervisor – Injection Molding
SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.
This role is embedded in Production/Injection Molding of our new state-of-the-art device manufacturing facility in North Charleston, South Carolina. For interested candidates there will be an opportunity to initially spend an extended period in our facility in Taiwan for induction/training.
- Supervise personnel and operations involved in medical device component injection molding
- Strict adherence to current Good Manufacturing Practice (cGMPs), established manufacturing practices and procedures, and compliance with Quality regulations and guidelines.
- Supervise all manufacturing activities and ensures safe operation of the molding department
- Coordinate and support molding production planning
- Review, trains molding Manufacturing Technicians
- Prepare documentation associated with the job duties of the department
- Ensure operations and practices comply with established procedures and records
- Ensure in-process tests and inspections are performed in accordance with standard procedures
- Assure accurate and complete production records; support documentation of production data and event/issue handling records
- Provide input during Health Authority inspections
- Acquire technical expertise on the function and control of applicable department equipment and techniques related to job function, and regulatory requirements for the molding operations
- Support evaluation, specification, installation, and validation of new manufacturing equipment as needed
- Maintain validated systems and re-validates existing systems in accordance validation procedures
- Incorporate value improvement programs and new processes from Engineering, EH&S, and OE as directed
- Serve as project member or project leader on improvement programs as needed
- Support manufacturing activities in other departments as instructed by manager
- Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes
- Bachelor’s Degree or equivalent experience
- Minimum 10 years injection molding-manufacturing experience; preferably related to high-volume manufacturing of medical device manufacturing
- Knowledge and experience in turnkey operation of (automated) production (hot runner molding and/or Robot handling) and related planning/logistics operations
- Ability to lead people and projects is required
- Excellent communication skills and ability to work in teams
- Experience in an FDA regulated manufacturing environment
- Ability and experience with automated records systems such as MES, EWM and SAP
- Experience in planning/organizing work, managing execution, checking results & revising the work plan in accordance with the daily work plan
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
- The ability to finger, balance, climb, stoop, stand, and walk.
- The ability to speak, listen, and understand verbal and written communication.
- While performing this job employee work involves sitting most of the time with walking and standing required only occasionally. This position may lift up to 10 pounds frequently or constantly to lift, carry, push, pull or otherwise move objects.
- Visual acuity to perform close activities such as: reading, writing, and analyzing; and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations.
- The working environment includes a variety of physical conditions including: noise, close proximity to moving parts and equipment, and exposure to chemicals; atmospheric conditions including: odors, fumes, and dust.
- Ability to work the hours necessary to support a 24/7 continuous manufacturing operation
- Competitive compensation package
- Modern working environment with state-of-the-art facilities and technologies
- Challenging assignments in a fast growing and innovative industry
- Position in a dynamic, international team of highly skilled professionals
- Various opportunities for personal and professional development within a global organization
Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents to our Talent Acquisition Department at RecruitUS@shl-group.com.Apply for this job