MAIN PURPOSE OF ROLE
Responsible for facilitating and executing to the CAPA process.
MAIN RESPONSIBILITIES
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Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.
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Participate in, or lead, the completion of CAPA projects, assuring compliance, quality and timeliness of records.
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Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills).
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Independently investigate, gathers data, and perform preliminary analysis.
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Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals.
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Lead meetings and communications for CAPA updates, information, and concerns.
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Responsible for assisting with metrics and reporting on regular basis in accordance with established procedures.
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Support team in the delivery and oversight of CAPA training program.
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Assist in the initiation, processing and completion of CAPA records in the electronic system.
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Execute and provide on-time completion of Quality Assurance engineering deliverables.
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Provide support and subject matter expertise during audits and inspections.
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Lead and/or contribute to continuous improvement initiatives and projects.
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Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
QUALIFICATIONS
Education
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Bachelors Degree (± 16 years) Preferably in the engineering, healthcare, or science fields.
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Associates Degree (± 13 years) With relevant medical device/quality system experience.
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Masters Degree (± 18 years) Preferred
Experience/Background
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Minimum 2 years
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Significant engineering and/or technical operational experience plus demonstrated competence.
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Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.
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Prior medical device experience preferred.
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Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.
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Solid communication and interpersonal skills.
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Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
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Advanced computer skills, including statistical/data analysis and report writing skills.
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Ability to work in a highly matrixed and geographically diverse business environment.
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Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
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Ability to leverage and/or engage others to accomplish projects.
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Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
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Multitasks, prioritizes and meets deadlines in timely manner.
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Strong organizational and follow-up skills, as well as attention to detail.
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Ability to travel approximately 20%, including internationally.
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Ability to maintain regular and predictable attendance.
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ASQ CQT, CQE, CQA certification preferred
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Six Sigma root cause analysis/problem solving training and experience preferred.
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Experience working in a broader enterprise/cross-division business unit model preferred.
