Fisher & Paykel Healthcare, Inc. Quality Engineer in New Zealand
About the company
Fisher & Paykel Healthcare is a world leader in the design, manufacture and marketing of medical devices, exporting to over 120 countries globally. We are an iconic New Zealand company with a consistent growth strategy ensuring an expanding range of innovative devices for use in respiratory care, acute care and the treatment of obstructive sleep apnea.
About the role
This position supports the Manufacturing function for the implementation of innovative technologies and advance Quality principles in order to drive continuous improvement and improve process quality. By utilizing data insights and analytics to identify and drive continuous improvements helps us drive Total Cost of Quality and create a better compliance environment.
You will work in partnership with Manufacturing and Engineering, the role is responsible for ensuring that products are manufactured in accordance with FDA/13485 regulations, applicable international regulatory requirements as well as company requirements.
The role will utilize Quality Engineering principles and problem solving skills to improve processes that are aligned with the overall Quality and Business vision. You will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. The role also enables effective deployment across the Quality Manufacturing Organization of procedures and methodologies to ensure high product/process quality as well as compliance with FDA and global quality system requirements.
Skills and Experience
- A University/Bachelor's degree in an Engineering, Scientific, or related field is required.
- minimum 2 years related experience in a quality engineer role
- Experience in the medical device field mandatory.
- Quality Engineer certification a plus.
- Process Excellence training or certification preferred (Lean, Six Sigma, DeX).
- Working knowledge of US and International regulations governing the medical device industry (i.e. GMP, GLPs, MDR, and ISO 13485: 2003) is required.
- Knowledge of fundamental quality engineering principles such as Process Validation, Design of Experiments, and Process Control & Capability required.
- Excellent communication skills (verbal and written) and problem solving skills required.
- Team player, able to work collaboratively cross-functionally as well as across business units required.
The role is based in NZ's largest city Auckland, and we will provide relocation assistance to move you & your family here. This is an opportunity which doesn't come up every day in a clean, safe politically stable country. Our friendly culture fosters innovation and an achievement-driven focused team. We offer exceptional benefits and a commitment to developing our employees. We look forward to receiving your application.
Reference #: 45380
Posted on: 19 Feb 2018
Location(s): New Zealand
Expertise: Quality/Regulatory Affairs
Job level(s): Indirect