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!
- QA/QC Technician: Formacoat LLC, a manufacturing company in Chaska, MN, is seeking a QA/QC 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 manufacturing lot-release testing, as well as serve as reviewer and/or approver for required documentation in a manufacturing setting. 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 Assurance and Quality Control activities associated with production and R&D support.
- Maintains Quality instrumentation and laboratory equipment.
- Expand Quality capabilities, including developing test method.
- Responsible for review of batch records and associated documentation in support of timely production batch disposition.
- 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.
- Evaluation and inspection of incoming raw material and outgoing finished goods.
- Performs Device History Record reviews to assure accuracy and compliance with Good Documentation Practice (GDP) regulations and internal requirements.
- 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.
- Assigning and/or assisting with the disposition of product.
- Compiles batch-to-batch data for quality trending and analysis.
- Follow GMP guidelines and adhere to SOPs and GMP requirements.
- Communicate QA issues and statuses with quality and manufacturing personnel.
- Work on multiple projects with changing deadlines and priorities.
- Experience working in med 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
- 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.