In this role, the successful candidate will be:
Responsible for overseeing and reviewing validation area processes and procedures. Prepares all protocols and reports involving validation tasks. Supports the validation process of new and modified equipment in partnership with the Research & Development, Facilities, and Quality departments.
- Provides technical expertise and guidance for the preparation and execution of validation protocols and reports.
- Reviews and investigates anomalies.
- Gathers data and performs analysis.
- Resolves and consults on applicable validation compliance and manufacturing process issues.
- Performs technical and validation compliance reviews for protocols and reports.
- Contributes at the project team level for validation activities.
- Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
- Reviews and develops manufacturing documents (WI, SOP, Forms, etc.).
- Other duties as assigned.
What does it take to be successful?
- B.S. degree or equivalent in engineering or related field.
- 3 years of related experience.
- Strong communication skills.
- Experience preparing and reading technical documentation.
- Working knowledge of standard machine shop equipment and process.
- Knowledge of medical and technical development.
- Ability to use MS Office and other manufacturing systems.
- Knowledge of Process Validations in medical device manufacturing environment.
- Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred.
- Troubleshooting and problem solving skills.
- Ability to learn technical concepts by reading work instructions and standard operating procedures, and completing on-the-job training.
- Proficiency in SolidWorks (and/or CAD) and fixture/tooling design is a plus.
Our Awesome Benefits!
Working for a growing innovative company like Argen means exciting opportunities for training and learning, career development and advancement from only the best in the dental industry. With all that hard work, Argen is committed to ensuring the welfare of its employees and provides an amazing benefit package that includes:
• Health/Dental/Vision Plans
• 401k with Employer Match
• Paid Vacation, Holiday and Sick Time
• Employee Events
• Wellness Programs
• Discounts for home, travel, entertainment, relaxation that includes Mobile phone service, Technology, Airline and Hotel, Theater/Theme Park tickets, Restaurants and so much more!