MAIN PURPOSE OF ROLE

Responsible for facilitating and executing to the CAPA process.

MAIN RESPONSIBILITIES

Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.Participate in, or lead, the completion of CAPA projects, assuring compliance, quality and timeliness of records.Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills).Independently investigate, gathers data, and perform preliminary analysis.Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals.Lead meetings and communications for CAPA updates, information, and concerns.Responsible for assisting with metrics and reporting on regular basis in accordance with established procedures.Support team in the delivery and oversight of CAPA training program.Assist in the initiation, processing and completion of CAPA records in the electronic system.Execute and provide on-time completion of Quality Assurance engineering deliverables.Provide support and subject matter expertise during audits and inspections.Lead and/or contribute to continuous improvement initiatives and projects.Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

QUALIFICATIONS

Education

Bachelors Degree (± 16 years) Preferably in the engineering, healthcare, or science fields.Associates Degree (± 13 years) With relevant medical device/quality system experience.Masters Degree (± 18 years) Preferred

Experience/Background

Minimum 2 yearsSignificant engineering and/or technical operational experience plus demonstrated competence.Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.Prior medical device experience preferred.Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.Solid communication and interpersonal skills.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.Advanced computer skills, including statistical/data analysis and report writing skills.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.Ability to travel approximately 20%, including internationally.Ability to maintain regular and predictable attendance.ASQ CQT, CQE, CQA certification preferredSix Sigma root cause analysis/problem solving training and experience preferred.Experience working in a broader enterprise/cross-division business unit model preferred.