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Lead Quality Assurance Engineer
2 months ago
The Senior Quality Engineer at Katalyst Healthcares and Life Sciences plays a crucial role in ensuring the highest standards of quality and compliance within our operations. This position is pivotal in driving continuous improvement initiatives and managing quality-related challenges.
Key Responsibilities:- Oversee and facilitate problem-solving related to quality issues and identify opportunities for ongoing enhancements.
- Lead and support Change Control processes to align with business objectives and foster continuous improvement.
- Provide expert guidance and validate relevant documentation associated with validations and change control.
- Manage Non-Conformance and Corrective Action Preventive Action (NC/CAPA) processes, ensuring the development and implementation of effective corrective action plans.
- Utilize statistical tools to analyze data and derive insights.
- Offer technical assistance to production teams in identifying and resolving operational challenges.
- Ensure adherence to compliance standards and quality system elements within the facility.
- Lead and engage in Risk Analysis initiatives.
- Participate in internal and external audits.
- Identify and recommend areas for continuous improvement.
- Review and endorse work instructions to ensure clarity and compliance.
- Own the process control plan and oversee its effective execution.
- Contribute to additional projects as necessary.
- A Bachelor's degree in a scientific discipline or a related field is required.
- A Master's degree is preferred; equivalent combinations of education, training, and relevant experience may be considered in lieu of a Bachelor's degree.
- A minimum of 5-7 years of experience in Quality Engineering or a related field within a regulated industry, ideally in medical devices.
- Familiarity with ISO 13485 and FDA 21CFR820 requirements, along with system development and management in the medical device sector.
- Proficient in statistical analysis, sampling plans, and root cause analysis.
- Six Sigma Black or Green Belt certification is preferred.
- Proficient in MS Office Suite and database management software.
- Demonstrated project management and leadership capabilities.
- Excellent written, verbal, and interpersonal communication skills.
- Able to thrive in a collaborative team environment.
- Skilled in managing diverse workloads and prioritizing tasks effectively.
- Attention to detail is essential.
- Possess a capacity for innovation and the ability to work independently.
