Injection Molding Quality TechnicianReq # JR - 023437 Location Opelika, Alabama, United States Job Category Manufacturing Date posted 06/25/2020
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Due to the nature of this position, a very high degree of initiative, leadership, teamwork and communication are required. This is a hands-on position that will work directly with the staff on the floor as well as the management, engineers, quality, and mold shop. The Injection Molding Quality Specialist is responsible for inspection of molded components, observing process of inspections, observing and auditing documentation and assisting with fencing and documenting when quality issues arise.
This position will also aid in training to the staff as well as audit the process. This position also provides technical guidance to engineering staff, engineering and maintenance technicians, and others as required.
Essential Duties and Responsibilities: The following duties and responsibilities generally reflect the expectations of this position but are not intended to be all-inclusive.
- Works with manufacturing, Quality and other functional groups on manufacturing regulatory compliance issues.
- Routinely inspects the quality of the product as an independent check within the production staff. The quality checks will follow the same inspection criteria and process. This person will inspect the entire area over the course of the shift a minimum of twice a shift.
- Will routinely audit the production staff for documentation of paperwork, and inspection of the processes.
- Will aid and train on inspections with new staff and retrain incumbent staff.
- Will change documentation when needed to update job instructions and documentation when needed.
- Will be proficient in the use of the CMM, Microscope, calipers, pin gauges, and all measure functions within Molding.
- Works with the PU Leads to determine if corrective action needs to be taken in process or quality issues need to be elevated.
- Works with PU Leads to properly fence and document any aberrations or issues that arise.
- Works with the Supervisors to develop thresholds within the documentation to determine when there is risk to the downstream process.
- Assists with the validation processes.
- Develops or participates in the development of solutions to problems specific to injection molding.
- Leads injection-molding-specific continuous improvement projects.
- Continuously monitors injection molding processes; analyzes and eliminates defects. Improves injection molding processes using lean tools and statistical data analysis.
- Study and recommend techniques to improve existing products and processes.
- Works with toolmakers and process engineers (or Injection Molding Support Engineers) to improve mold performance and reliability.
- Assess results for application, validity and conformance to specifications. Recommend material and process specifications.
- Develops manufacturing process flowcharts, including defining people and material flow issues.
- Selects sound techniques to solve problems and make design recommendations.
- Utilizes engineering tools to solve straightforward problems (e.g., FMEA, Finite Element Analysis, Process Modeling, Design of Experiments, Mold Flow, SPC, software development).
- Provides technical guidance to others (internal and external) as required.
- Maintains confidential information as such.
- Performs other duties as assigned.
Job Requirements (Education, Experience and Qualifications):
- Manufacturing experience.
- Strong accountability and ownership.
- Strong leadership and project management skills.
- 5+ years of medical device manufacturing experience.
- Knowledge of ISO, GMP, FDA guidelines (21CFR820), purchasing practices, and process & product validation.
- Understanding of TPM and 6S. Demonstrated stop and fix mentality.
- Demonstrated solid data analysis skills, ability to utilize TQM methods (e.g. "six sigma").
- Ability to diagnose problems and recommend solutions in assigned area.
- Basic understanding of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques preferred.
- Ability to prioritize and execute multiple projects.
- Excellent trouble shooting and problem-solving skills in process and equipment.
- Experience with computer measurement systems (CMM).
- Ability to articulate how own role ties within function or discipline.
- Demonstrated ability to work in a team environment, with advanced leadership skills.
- Demonstrated initiative and sound judgment.
- Desire to continually learn to keep up with changing technology.
- Ability to communicate effectively both verbally and in writing.
- Proficient computer skills including familiarity with word processing, spreadsheets, and graphics.
- Ability to interpret and adapt internal guidelines.
- Exude a passion for new technology development.
Physical / Safety Requirements
- Physical requirements for a position will vary. These must be reviewed with the supervisor and should be attached here.
- Must be able to work in an environment without daylight / windows
- Ascends / descends ladders to access machinery
- Lifts and / or moves up to 50 pounds, and occasionally lifts and / or moves in excess of 50 pounds using lifting aids, techniques, or appropriate assistance
- Duties may require overtime work, including nights and weekends
- Use of hands and fingers to manipulate equipment is required
- Requires standing, walking, bending, pulling, pushing, climbing and crawling.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Pay Transparency Policy
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.