What are the responsibilities and job description for the Quality Engineer II position at Katalyst HealthCares & Life Sciences?
Responsibilities
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Design and conduct experiments for process optimization and/or improvement.
Appropriately document experiment plans and results, including protocol writing and reports.
Lead process control and monitoring of CTQ parameters and specifications.
Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
Lead the investigation, resolution and prevention of product and process non-conformances.
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
Lead in the completion and maintenance of risk analysis.
Work with design engineering in the completion of product verification and validation.
Work with microbiology to ensure appropriate environmental monitoring and that. microbiology requirements are considered in product and process development activities.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Requirements
2-5 years Engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
Solid communication and interpersonal skills. Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
Advanced computer skills, including statistical/data analysis and report writing skills.
Prior medical device experience preferred. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). ASQ CQE or other certifications preferred.
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Design and conduct experiments for process optimization and/or improvement.
Appropriately document experiment plans and results, including protocol writing and reports.
Lead process control and monitoring of CTQ parameters and specifications.
Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
Lead the investigation, resolution and prevention of product and process non-conformances.
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
Lead in the completion and maintenance of risk analysis.
Work with design engineering in the completion of product verification and validation.
Work with microbiology to ensure appropriate environmental monitoring and that. microbiology requirements are considered in product and process development activities.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Requirements
2-5 years Engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
Solid communication and interpersonal skills. Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
Advanced computer skills, including statistical/data analysis and report writing skills.
Prior medical device experience preferred. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). ASQ CQE or other certifications preferred.
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
