Sr. Manager, Capa And Complaints

MAIN JOB RESPONSIBILITIES / COMPETENCIES

CAPA System

1.Manage all aspects of Quality Events, Nonconformance (NC), Corrective Action/Preventive Action (CAPA), and planned deviations during emergent issues that may arise throughout site operations. This includes identification, root cause analysis, and health risk assessment, and documentation of the emergent issues.

2.Lead Material Review Board (MRB) meetings with NC record owners and cross-functional representatives.

3.Lead CAPA review meetings with CAPA record owners.

4.Coordinate creation of deviation records to address any planned actions deviating from current procedures or specifications.

Complaints

5.Manage all aspects of complaint handling team activities to ensure that the process is compliant with applicable domestic and international regulations (i.e. U.S. Food and Drug Administration-FDA; European Economic Area Medical Device Directives; Canadian Medical Device Regulation; Japan Pharmaceuticals and Medical Devices Agency

• PMDA) and other appropriate regulations and guidelines, as well as Company quality system requirements.

6.Continuously review the complaint handling process for business relevance, efficiency, and compliance to U.S. and international regulations. This activity includes exploration and development of automation for aspects of the complaint handling process and methods.

Other Duties

7.Support external audits and inspections, including the FDA, Notified Body and other governmental agencies, with respect to communications related to the CAPA system and complaints.

8.Develop and monitor departmental metrics to regularly report status of the CAPA system and complaints to Executive Management.

9.Hire, manage, mentor, retain, and monitor staff.

10. Other duties as assigned.

REQUIREMENTS

EDUCATION & TRAINING

• Bachelor's degree in scientific field or equivalent.

EXPERIENCE

• Five (5) years experience in an FDA-regulated environment, preferably with quality management experience.

• Experience with the review, statistical analysis, and presentation of scientific data is preferred.

SKILLS

• Strong statistical, analytical, and data-processing skills.

• Excellent written and oral communication, and technical writing and editing skills.

• Ability to manage and prioritize multiple projects and organize resources to meet business objectives.

• Able to influence, build consensus, and drive results across cross-functional groups.

• Good interpersonal effectiveness, relationship building and people management skills.

Pay range is $160-$190k

• Final compensation will depend on experience.

STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.