Quality Design Specialist
2 weeks ago
Seeking quality or regulatory officer from a food or pharma background
- Work with the design team to ensure medical devices meet exacting standards
- Great organisation offering excellent career prospects
**About the role**
An exciting opportunity has arisen for a bright, energetic and self-motivated Quality / Design Control Specialist to provide support to new product development and market launch by writing and managing the Documentation for Design Development and Production process. You will be a critical bridge between the R & D and Operations team Where you will:
- Work alongside the design team to ensure new medical devices meet highly regulated standards
- Act as the 'go to person' for regulatory advice throughout the design process
- Lead and support risk analysis activities
- Lead and join design reviews of new and modified products
**Skills & Experience**:
- A degree or higher in science or engineering
- Experience working in regulatory or quality focused role in a highly regulated environment
- A working knowledge of the medical electrical equipment standard ICE 60601 is an advantage but not essential
- Knowledge of standards such as ISO13495 or ISO14761, or the ability to read, interpret and understand these standards at a fast pace
- A superior eye for detail and desire to get things done right the first time
- Knowledge of risk management and design control practices
**Benefits**
- A rewarding role providing ongoing challenge
- Great remuneration
- Work with a high performing, energetic team who are at the 'top of game'
- Excellent career prospects within a rapidly growing NZX listed company
- South Auckland location with free parking
**About the company**
Award winning and privately owned, this South Auckland Medical Device manufacturing company have built and retained an excellent reputation for their commitment to quality and unique product offering. They have developed cutting edge tissue regeneration technology, with the main emphasis of the company being improvement of patient welfare, simplifying operating procedures and reducing healthcare costs.
**How to apply**
Click APPLY or contact Belinda on 09 300 3121 during office hours for a confidential discussion.
- Scitex specialises in permanent, contract and temporary recruitment - and has done since 1987. We are here to engineer better Mondays. We love connecting talented people with great work opportunities in workplaces where you can thrive and make a meaningful difference._
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