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 years
• Significant 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 preferred
• Six Sigma root cause analysis/problem solving training and experience preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.