Senior Quality Systems Engineer

Fisher Paykel Healthcare; San Diego (CA); On-site; USD 67,000 - 101,000; Full time

Benefits offered by this job

Employee share program

Profit share bonus

Life insurance

Health insurance discounts

Training programs

Career progression

Free parking

Job summary

Fisher & Paykel Healthcare is seeking a Senior QSE to drive QMS improvements and act as a subject matter expert for Design Controls.

You will partner with product development, clinical, marketing and regulatory teams to ensure compliance with QMS and international regulations as products reach markets.

The role requires 5+ years in medical devices, a science/engineering degree, and strong risk management and CAPA leadership capabilities.

Qualifications

• Minimum 5+ years in medical device industry with Design Quality Engineering.
• Tertiary qualification in Science or Engineering.
• Understanding of 21 CFR 820 and ISO 13485.
• Experience with verification and validation activities.
• Knowledge of ISO 14971 Risk Management.
• Familiarity with FDA and EU regulations.
• Experience leading CAPAs.
• Experience with change control.
• Exposure to statistical analysis techniques.
• Usability engineering experience preferred.
• Holistic approach to product development.

Responsibilities

• Lead QMS improvements and act as SME for Design Controls.
• Provide training and guidance to teams.
• Collaborate with product development, clinical, marketing and regulatory teams.
• Ensure compliance to QMS and regulatory requirements.

Skills

Quality Engineering

CAPA leadership

Change control

QMS compliance

Regulatory knowledge

Risk management

Communication skills

Statistics awareness

Usability engineering

Product development

Education

Bachelor's in Science or Engineering

Job description

Join a team of good people doing good work with intent. People like you, who care to make a difference.

About The Opportunity

Our strong focus on research and development creates a regular flow of new Fisher & Paykel Healthcare products. To enable our ongoing success, we depend on the technical expertise of our Design Quality team, who ensure our products get to market as fast as possible while meeting and sustaining customer, business and international regulatory requirements.

We have 2 positions available - ones within our Infant Care team and the other one with the Invasive Ventilation and Humidification (IV&H) team based in our head office in Auckland, New Zealand. Immigration and relocation support would be provided to our preferred candidate.

Infant Respiratory Care has a vast range of new and existing Infant Care products - it’s an exciting area to be a part of! In your role you will partner with product development, clinical, marketing and regulatory teams to release newly developed products to various markets. You will also support the compliance of existing products in current and expanding markets.

IV&H has an abundance of mature products and exciting new opportunities. In your role you will partner with product development, clinical, marketing, regulatory, operations and other quality teams to support the compliance and improvement of products currently in the market.

As Senior QSE in both of these teams, you will also be responsible for identifying and implementing Quality Management System (QMS) improvements, as well as being a subject matter expert for Design Controls.

You will provide training, development and guidance to support the achievement of Infant Care’s (or IV&H’s) business plan and ensure compliance to the QMS and regulatory requirements.

About You

We are looking for someone with:

• A minimum 5+ years related experience in the medical device industry, or a similar highly regulated industry, with specific experience in Design Quality Engineering.
• A tertiary qualification in Science or Engineering.
• An understanding of quality management systems such as 21CFR820 and ISO 13485.
• Experience with product verification and validation activities.
• A strong understanding of Risk management (ISO 14971).
• An understanding of FDA and international regulations, including the EU.
• Experience leading effective CAPAs
• Experience with change control
• Exposure to statistical analysis techniques.
• Ideally some experience in usability engineering.
• A holistic approach to product development.

You will also have:

• Excellent communication skills with the ability to influence, negotiate and challenge with respect and diplomacy.
• An ability to build relationships at all levels within the organization.
• An ability to make risk-based, data-driven decisions
• A curious and inquisitive nature and a continuous improvement mindset.

Working With Us

Care to join a supportive environment? Fisher & Paykel Healthcare foster an inclusive work environment founded on our culture of care and cooperation. Here you’ll have the trust and support to generate ideas, solve problems and do your best work.

• Employee share purchase scheme
• Discretionary bi-annual Profit share & Annual performance-based salary Review
• Life, Critical illness and Income Protection Insurance
• Discounted Health Insurance & other Banking and Insurance discounts
• Active Social clubs & community groups
• In-house training programs from external providers & excellent career progression opportunities
• Free Parking, beautiful campus with green spaces & Subsidised Cafés
• Access to state-of-the-art facilities

About Us

Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally.

Our commitment to care unites us. Here, we’re driven to improve patient care and outcomes through inspired and world-leading healthcare solutions.

We focus on nurturing a positive and inclusive culture based on trust and respect. In New Zealand, our employee-led communities, Spectra (rainbow), Manaaki (Māori) and Women in Engineering play an important role in this culture. We also have a commitment to creating a positive lasting impact on society, shown by our support of New Zealand organisations such as Diversity Works NZ, Pride Pledge and Global Women.

We are dedicated to designing our recruitment process with care and empathy to support all candidates, regardless of identity, background, and experiences. Should you require support or adjustments during our process, please let us know at [e-mail].