Senior Quality Assurance Manager- Investigations
ResMed
The primary role of Senior Manager, Field Investigations is to provide quality leadership, be responsible for investigation teams and engineers, driving capability development and providing input into their individual performance process. The Senior Manager is to mentor and lead a team of engineers conducting engineering activities required for investigation of released products, including (but not limited to) Quality issues, Reliability Engineering and Product Analytics. The Senior Manager works closely with Global Product Quality, Quality Systems, Supply Chain, Product Development, and Regulatory Affairs to ensure business-wide quality excellence. Key deliverables include systems and processes, complaint investigation management and associated reporting. Let's Talk About Responsibilities
- The primary objective of Field Investigations Engineering(General) specialization is to assess patient risk, inspecting, testing and evaluating the returned devices from the field and escalating new issues when required as part of the investigation process.
- Drive the teams to perform right-sized engineering investigations in a timely manner to identify root cause for released product.
- Identify and deliver on improvement opportunities to achieve ongoing operational excellence and efficiency and taking the necessary actions to comply with medical device regulations. Ensure customer feedback is appropriately escalated and analyzed for insights to drive product, process and service improvement and to ensure compliance to medical device regulations.
- Ensure the application of engineering skills and technology to the investigation process.
- Mentor, develop, motivate and support the leaders of the investigations teams – whether they are direct reporting or indirect.
- Develop teams investigation skills and technology to match ResMed's products.
- Are assuring compliance to in-house and/or external specifications and standards (i.e. GMP and ISO standards).
- Focuses on the development and implementation of strategic and operational objectives that help achieve organizational mission. Implements organization strategies through the effective direction and management of employees and resources.
- Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
- Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
- Manages professional employees and exercises full management authority, including performance reviews, pay decisions, recruitment, discipline, termination and other personnel actions.
- Direct and influential leadership and continuous capability development of teams and leaders.
- Working with other engineering disciplines in global offices.
- Working with other sections of the company including Regulatory Affairs, Product Development, Applied Research, Supplier Alliance, Technical Service, Manufacturing and Regional teams.
- Liaising with contractors and external suppliers.
- Logical and methodical approach to problem solving.
- Managing investigation and issue resolution with respect to stakeholder management.
- Working within a strict quality system and regulatory environment.
- Proficiency in MS Word, Excel and PowerPoint.
- Extensive knowledge across the following:
- Post market surveillance, analytics and insight creation.
- Electronic and electrical components.
- Electronic design technologies.
- Manufacturing process.
- Materials.
- Mechanical design
- Bachelor's degree.
- Minimum of 8+ years' experience in Quality, Regulatory, or Engineering roles within a regulated industry (medical devices, pharmaceuticals, or equivalent).
- Strong knowledge of FDA Quality System Regulations, GMP, and ISO standards.
- Ability to solve complex quality problems with broad business impact.
- Bachelor Engineering with senior-level experience in Quality management within a regulated medical industry.
- Formal root cause analysis methodologies
- Experience in volume manufacturing.
- Knowledge of total quality and best practices.
- Extensive experience with business management systems, GMP, Lean, 5S, Six Sigma methodologies, and modern digital tools.
Vacancy posted 3 days ago
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