Quality Systems Manager, Medical Devices & Design Assurance

Fisher Paykel Healthcare; New Zealand; On-site; NZD 120,000 - 160,000; Full time

Benefits offered by this job

Employee share purchase scheme

Discretionary profit share

Paid Parental Leave

Life Insurance

Disability and income protection

Discounted Health Insurance

Internal training programs

Purchasing privileges for Fisher & Pay

School holiday programme subsidy

Banking and Insurance discounts

Free Parking

Annual Salary Review

Internal promotion opportunities

Job summary

Fisher & Paykel Healthcare is seeking a QSE Manager to lead a team delivering quality system engineering and regulatory support for key product groups. You will drive design controls and ensure compliance with ISO13485, ISO14971 and FDA CFR 820 while partnering with cross-functional teams across design, operations, marketing and clinicals.

You should bring 5+ years in medical devices, strong leadership, and a track record of influencing outcomes to deliver safe, effective products.

Qualifications

• A tertiary qualification in engineering or a related technical field is required.
• Minimum 5 years’ medical devices experience is required.
• Experience applying statistical and analytical techniques in QA for product development or NPI is essential.

Responsibilities

• Lead a team of Quality System Engineers providing technical engineering and quality system support for design teams.
• Demonstrate leadership to deliver results and drive change with cross-functional stakeholders.
• Ensure compliance with ISO13485, ISO14971 and FDA CFR 820 and collaborate with product design, operations, marketing and clinical teams.

Skills

Leadership

Influencing

Negotiation

Regulatory knowledge

Statistical analysis

Analytical techniques

Quality systems

Education

Engineering or related technical field

Job description

Fisher & Paykel Healthcare is seeking a QSE Manager to lead a team delivering quality system engineering and regulatory support for key product groups. You will drive design controls and ensure compliance with ISO13485, ISO14971 and FDA CFR 820 while partnering with cross-functional teams across design, operations, marketing and clinicals.

You should bring 5+ years in medical devices, strong leadership, and a track record of influencing outcomes to deliver safe, effective products.