Manager, CAPA Compliance

About the Position

With a passion for life, join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Responsibilities

• Lead and maintain the Healthmark CAPA program.
• Ensure CAPA activities comply with FDA QMSR, ISO 13485, internal quality procedures, and applicable regulatory requirements.
• Review and approve investigations for adequacy, completeness, and regulatory compliance.
• Maintain CAPA metrics, KPI reporting, and process effectiveness indicators.
• Drive timely closure of CAPAs while ensuring quality and regulatory compliance.
• Oversee CAPA governance, prioritization, escalation, and management review reporting.
• Identify systemic quality issues and opportunities for continuous improvement.
• Lead CAPA remediation programs supporting FDA inspection preparation, FDA 483 remediation, Warning Letter remediation, Consent Decree activities, internal audit findings, external audit observations, and Management Review actions.
• Assess historical CAPA records for compliance gaps and remediation opportunities.
• Strengthen investigation quality, data integrity, and documentation practices.
• Facilitate issue resolution across multiple functional areas.
• Lead CAPA review boards and quality review meetings.
• Provide recommendations and subject matter expertise regarding CAPA-related quality and compliance risks.
• Participate in third-party audits (FDA, Notified Body) of the Quality System and assist with providing responses to any observations made during those audits.
• Develop and provide internal training on CAPA Process and Procedures and the applicable QMS software.
• Assist management with ongoing Quality improvement initiatives. Tracks or trends Quality System Metrics.
• Determine the source of Quality problems, make recommendations for improvement, and assist with corrective and preventative actions.
• Foster a culture of accountability, compliance, and continuous improvement.
• Approve timesheets for vacation/paid time off requests for Direct reports.
• May be required to perform other duties as assigned or as needed.

Requirements

• Advanced Root Cause Analysis experience.
• Strong statistical problem-solving skills.
• Experience with data-driven decision making.
• Ability to evaluate large volumes of quality records and identify systemic issues.
• Strong technical writing and documentation review skills.
• Attention to detail and high level of accuracy.
• Demonstrated ability to create and update standard operating procedures (SOP) and work instructions (WI).
• Knowledge of current applicable Quality and Regulatory standards, guidance documents, and industry working groups.
• Communicating both orally and written with members of the organization, as well as external parties relating to Quality issues.
• Organizing and prioritizing daily duties.
• Must be a team player and able to work well with teams representing all areas of the organization.
• Problem solving and decision making – identifies and solves problems, acts decisively, and shows good judgement.
• Maintaining appropriate focus on short-term and long-term goals.

Minimum Requirements

• 8+ years of Quality Assurance, Quality Engineering, Quality Systems, or Regulatory Compliance experience within the Medical Device industry.
• 3+ years of leadership experience with direct reports.
• Demonstrated ownership of CAPA systems and quality improvement initiatives.
• Experience managing complex investigations and quality remediation programs.
• Experience supporting FDA inspections and regulatory audits.
• Experience managing cross-functional teams and driving organizational change.

We Offer

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

About the Company

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Location

• City: Fraser
• Country: US
• Remote Work: 1-2 days at home (site based)

Salary

• Range: $120,000-$150,000 per year depending on experience

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status, or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.