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Lead Quality Assurance Systems Engineer
2 months ago
At Integra LifeSciences, we are dedicated to making a significant impact in the healthcare sector. By joining our team, you will engage in meaningful work that drives innovation and enhances patient outcomes.
Key Responsibilities:
As a Lead Quality Assurance Systems Engineer, you will:
- Oversee the maintenance of the Quality Management System (QMS), ensuring adherence to regulatory standards and internal procedures.
- Identify deficiencies within the QMS and spearhead initiatives to address and rectify these gaps.
- Manage the Quality Manual and associated procedures, ensuring their relevance and compliance with business needs.
- Evaluate current and future procedural requirements for the organization.
- Play a pivotal role in external Quality System audits, providing expertise and support during evaluations and inspections.
- Facilitate the initiation and resolution of Non-Conformance (NC) records within the electronic system.
- Lead discussions and updates regarding NCs to ensure timelines are met.
- Collect and analyze Quality Metrics regularly, in line with established protocols.
- Conduct independent investigations, gathering data and performing preliminary analyses.
- Report on Key Performance Indicators to ensure processes are followed and non-conformities are minimized.
- Provide seasoned quality assurance support to manufacturing, product development, procurement, and other departments.
- Mentor junior Quality Engineers and offer training on quality awareness and processes.
- Stay updated on evolving trends in Quality Management Systems and collaboratively implement necessary changes.
- Lead special projects and contribute to continuous improvement initiatives.
- Prepare reports and present updates during project meetings.
- Ensure project goals are achieved within set budgets.
- Plan and track project tasks for effective monitoring.
- Participate in various meetings, providing clear instructions and follow-ups.
- Independently determine the approach for completing assigned responsibilities.
- Coordinate and lead Quality Review meetings.
- Communicate effectively with all levels of management, peers, and stakeholders, ensuring timely escalation of quality issues.
Minimum Qualifications:
A Bachelor's degree in a scientific discipline is required, along with a minimum of 8 years of experience, preferably in the medical device sector. Candidates should possess strong analytical abilities, exceptional writing skills, and effective interpersonal skills, or a combination of relevant experience and education.
Experience with Non-Conformance (NC) and quality systems, as well as proficiency in quality tools and methodologies, is essential. A comprehensive understanding of FDA Quality Systems Regulations, ISO 13485, and other global standards is required. Previous experience in a high-volume manufacturing environment is preferred.
Strong verbal and written communication skills are necessary, with the ability to engage effectively at various organizational levels. Candidates should demonstrate excellent organizational skills, capable of multitasking, prioritizing, and meeting deadlines. Proficiency in reading and writing in English is mandatory.
Integra LifeSciences is an equal opportunity employer, committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
