Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- Proactively investigating, identifying, and implementing best-in-class quality engineering practices.
- Providing focused quality engineering support and assuming responsibility for timely and effective coordination and execution of assigned development project activities.
- Establishing effective corrective action plans and leading in implementing quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Acting as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Reviewing and approving product and process qualifications, validations, and other change control-related documentation.
- Developing product/process assurance plans, which include all required elements, and identifying and implementing effective process control systems to support the development, qualification, and ongoing manufacturing of products.
- Generating internal quality documentation such as quality plans, standard operating procedures, and inspection procedures.
- Participating in product review boards, identifying non-conformance trends, and developing technical investigation plans, including investigating and analyzing customer/internal complaints.
- Performing analytical measurements and experiments to qualify or resolve product and process issues.
- Developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans, and quality/regulatory compliance operating procedures to meet FDA and ISO requirements.
- Tracking quality trends and initiating action items to resolve issues while managing assigned corrective actions.
- Monitoring field quality and analyzing field returns to determine root causes.
- Providing training and support for quality system processes and quality engineering practices.
Requirements:
- A bachelor's degree (minimum) in engineering, life sciences, or a related field.
- 3 to 10 years of progressively responsible experience in medical device quality assurance.
- One to two years of auditing experience is preferred.
- Certification as a CQA, CQE, or CQM and membership with ASQ are highly desirable.
- Advanced computer skills to efficiently utilize quality systems and tools.
- Strong writing, mathematical, and statistical skills for data-driven decision-making.
- Adept at managing multiple projects and meeting deadlines with precision.
- Proficient in verbal and written communication to effectively convey complex information.