Experience / Education:
- High School Degree or equivalent
- Minimum 5 years of experience in a production environment (or equivalent)
- Medical Device or other regulated industry experience preferred.
- Experience working in a GLP/GMP/ISO environment preferred.
- Experience with Aseptic Technique preferred.
Knowledge / Skills / Abilities:
- Ability to use judgment, clear problem-solving and decision-making skills.
- Demonstration of minimum strong customer service and project management skills.
- Ability to work under limited supervision and to handle complex problems
- Excellent organizational and interpersonal skills.
- Ability to communicate effectively with all levels of the organization
- Knowledge of general ISO 13485 /GMP regulations
- Proficient in Oral & Written communication skills
- Need to be able to clearly speak, read, write and understand English
- Proficient in Microsoft (e.g. Excel, Word, Outlook)
- Working knowledge & application of Electronic Document Management systems.
- Ability to apply continuous improvement methodologies.
- Must be able to work in a Lab setting with exposure to biohazards and chemicals
- Must be able to wear appropriate PPE
- Must be able to work in environment with minimal noise levels
- Ability to stand/sit for long periods of time
- Clarity of vision (Or corrective lenses).
- Ability to identify and distinguish colors
- Must be able to perform activities with repetitive motions, and good manual dexterity
- Ability to lift 50 lbs occasionally
- Ability to crouch, bend, twist and reach
- Ability to push/pull 50 lbs occasionally
- Ability to work in variable temperatures high to freezing
- Inside working conditions
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.