Supervisor - Quality and Reliability Engineer

About our client

For more than 80 years, our client’s engineers and product specialists have partnered with customers to produce highly engineered connectivity and sensing solutions that make a connected world possible. Their focus on reliability, durability, and sustainability exemplifies their commitment to progress. The unmatched range of their product portfolio enables companies, large and small, to turn ideas into technology that can transform how the world works and lives tomorrow.

Job

Responsibilities:

• Manage the day-to-day activities of the team in a safe environment and be responsible for Health and Safety goals.
• Deliver on all KPIs that help the business achieve its objectives.
• Lead and drive QA initiatives within the functional area.
• Provide quality input and support to Manufacturing, Engineering, Prototype, and Commercial functions.
• Lead, coordinate, and maintain risk assessment documentation (e.g., FMEAs).
• Investigate the root cause of quality issues and implement timely and effective corrective actions to prevent recurrence for both customer and internal issues.
• Strategically lead new product introduction (NPI) and contract reviews from a QA perspective.
• Prepare and update Operations procedures and associated documentation.
• Overall responsibility for functional area GMP standards and compliance, including promoting quality awareness.
• Establish inspection standards, sampling plans, and test methods.
• Report quality metrics to management.
• Develop strong links with customer organizations and other project stakeholders.
• Review validation documentation for the functional area.
• Perform and support internal and external audits to ISO and FDA requirements.
• Actively contribute to the continuous improvement of the Quality Management System.
• Supervise and provide direction to quality personnel.
• Perform other tasks as directed by the Operations Quality Manager in line with company goals.

Requirements:

• Level 8 degree in Science, Engineering, or related field.
• Minimum of 5 years industry experience in a medical device manufacturing environment.
• People management experience.

Key Requirements

• Clear understanding of medical device quality systems and requirements, including measurement techniques.
• Experience managing and leading a team.
• Strong CAPA experience.
• Strong root cause analysis and problem-solving skills.
• Knowledge of FDA and ISO Quality systems for medical device companies is desirable.
• Experience in new product introduction (NPI) and manufacturing process transfers is desirable.
• Demonstrated excellent organizational skills and ability to work independently.
• Excellent written and verbal communication skills.