Formacoat is a leading provider of contract medical device coating services, and we are proud to collaborate with some of the greatest medical device companies in the world. Come join our exciting and friendly workplace!
- QC Lab Technician: Formacoat LLC, a manufacturing company in Chaska, MN, is seeking a QC Lab Technician for immediate hire. Candidate will work within the Quality group to ensure compliance of manufacturing processes in a GMP/ISO 13485 environment. This person will perform regular supplier and manufacturing lot-release testing, as well as develop and improve the testing capabilities of the company to meet ever changing customer needs. This position is an active and project-oriented position. Every day can be different with changing responsibilities, priorities and personnel interactions. Candidate will work to maintain a quality system that complies with the requirements of the International Quality Standards (ISO 13485) with the direction of the Quality Manager.
- Perform Quality Control lot-release inspection activities associated with manufacturing production and R&D/Engineering support.
- Expand Quality inspection and testing capabilities, including onboarding new equipment, developing new test methods, and improving current test methods.
- Maintains Quality instrumentation and laboratory equipment.
- Provides assistance to site personnel performing deviation investigations, CAPAs, and change controls.
- Focused primarily on providing support and guidance on non-complex and routine quality-related issues.
- Sampling, evaluation and inspection of incoming raw material and outgoing finished goods.
- Coordinate instrumentation and equipment calibration and maintenance activities.
- Drive timely review of checklists and data logs.
- Receives minimal supervision on routine work assignments. Receives specific instruction on new assignments.
- Identifies and proposes Quality Process and system improvements.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place and current.
- Assigning and/or assisting with the disposition of product.
- Compiles and analyzes lot-to-lot data for trending.
- Ensure all testing and reporting adheres to ISO requirements.
- Communicate Quality-related issues and statuses with quality and manufacturing personnel.
- Work on multiple projects with changing deadlines and priorities in a flexible manner.
- Experience with various wet chemistry/bench chemistry techniques and equipment (pH, conductivity, viscosity, % solids determination, UV-Vis, FTIR, etc.) preferred.
- Experience working in medical device or pharmaceutical manufacturing environment preferred
- Experience working in a regulated environment (GMP, ISO 9001, or ISO 13485) preferred
- Detail-oriented, ability to get along with a variety of different personalities, and displays multitasking skills
- Strong verbal and written communication skills
- Strong technical writing and review ability
- Proficient in Good Laboratory Practices and Good Documentation Practices.
- Quick learner, Effective interpersonal skills
- Excellent oral and written communication skills
- Full-time Production Technician / Machine Operator: Formacoat LLC, a manufacturing company in Chaska, MN, is seeking Production Technicians and Machine Operators for immediate hire. Responsibilities include running production equipment, performing manual operations in a clean room and the ability to follow written instructions to produce medical devices. Both positions would be responsible for operating custom and supplied production equipment, identifying non-conforming material, and keeping accurate production record documentation.