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Job Description
Quality Assurance Manager sought for a 2-year contract with potential permanency, focusing on regulatory compliance and product portfolio management.
The Quality Assurance Manager operates within the Quality Assurance organization, providing feedback and support to stakeholders to meet corporate and regulatory timelines. Key responsibilities include:
- Leading a small team to achieve quality assurance and technical support goals
- Identifying and addressing quality issues related to product design, manufacturing, and safety quality programs
- Assisting the complaints team in investigating and resolving issues in a timely manner
- Proactively investigating and addressing customer feedback and repair data to identify potential issues
- Coordinating and ensuring timely review and approval of quality agreements
- Ensuring appropriate training is identified for the service centre
- Managing the CAPA process for the device
- Coordinating the service Centre processes and key performance indicators
- Coordinating the audit program schedule for the service centres
- Ensuring all documentation complies with device requirements, applicable regulations, and ISO standards
EHS Responsibilities:
- Ensuring compliance with Environmental Health & Safety standards and regulations
- Demonstrating accountability for EHS performance through active participation and support of the EHS program
- Reporting work-related injuries or illnesses to employee health and assisting in investigations
- Participating in EHS programs and attending assigned EHS training sessions
- Striving to meet EHS goals
Requirements:
- Third-level qualification in a related field
- Minimum 5 years of experience in the medical device industry, including at least 3 years in progressively responsible roles and experience leading a project
- Auditor or lead auditor qualifications are an advantage
- Strong interpersonal skills, capable of working independently or in teams with minimal supervision
- Proven people management skills through managing staff, mentoring new hires, or leading training programs
- Proactive attitude, excellent organizational skills, and the ability to manage multiple projects while meeting deadlines
- Strong analytical, critical thinking, and problem-solving skills, including the ability to perform root cause analyses and quality data evaluations
- Working knowledge of recognized Quality Management Systems and global medical device regulations
- Proficiency in MS Office applications and familiarity with Power BI is a plus
- Experience working with electronic quality management systems
- Experience with post-market surveillance is advantageous
- Willingness to travel internationally (approximately 5-10% annually)