Staff CAPA Engineer

THE OPPORTUNITY:

This role is responsible for implementing and progressively improving the CAPA process and electronic system within the Quality Management System. Reports to the Regulatory Compliance Manager for the business unit.

THE JOB RESPONSIBILITIES:

Lead, mentor, and motivate a team of Quality Engineers as an individual contributor, but a key success factor in mentoring the team overall.

Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.

Accountable for leadership and oversight of the CAPA system, and associated deliverables.

Provide guidance, insight, and training to the team and the wider business around CAPA process, quality standards, and regulatory requirements.

Lead and/or contribute to continuous improvement initiatives and projects.

Provide subject matter expertise during audits and inspections.

Represent CAPA QA in cross-functional meetings (site and division).

High proficiency in leading meetings and communications for QA system information, concerns, and updates.

Lead, develop, and mentor others with QA data analysis, trending, and reporting. High proficiency with reporting and publishing weekly, monthly, and quarterly metrics.

Adept at staying current with organizational and industry information and routinely mentors/leads other members of the organization on quality assurance practices.

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Bachelor's degree in Engineering, Technical Field, Life Science, or closely related discipline or an equivalent combination of education and work experience

Minimum 8 years in Quality or related field experience.

Previous CAPA and/or Quality Assurance/engineering experience and demonstrated use of quality tools/methodologies.

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 leverage and/or engage others to accomplish projects.

Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.

Ability to travel up to approximately 20%, including internationally.

PREFERRED QUALIFICATIONS:

Master's degree preferred.

Prior medical device experience is strongly preferred.