Continuous Improvement Coordinator

Summary:

The Continuous Improvement Coordinator will serve as an Auditor/Lead Auditor who is responsible for performing/coordinating internal audits of the quality management system for North America locations. The auditor performs and reports internal/supplier quality audits to provide an independent assessment of the compliance posture of the operation, and the effectiveness and adequacy of the quality system, procedures and practices which governs the operation. The individual performs internal/supplier quality audits against Medical Devices Regulations and Standards, Corporate Quality Manual, Corporate Policies, Divisional and Plant Procedures. The Continuous Improvement Coordinator will be empowered to escalate issues observed outside of internal/external Audit settings, and pursue more efficient processes and improvements to the Quality Management System to ensure compliance and benefit the Invacare America business.

Essential Functions:

* Supports audit readiness by tracking preparation for and execution of external audit activities, including tracking corrections and responses to external audit findings.

* Collaborate with local associates on preparation for external audits as part of an audit preparation team.

* Perform internal audits of other Invacare sites.

* Prepare internal audit workpapers with supporting evidence.

* Communicate internal audit findings to auditees.

* Identify potential areas for improvements and escalate those issues to the Process Owners, Managers responsible, and/or others as appropriate.

* Monitors external audit metrics and reports to Vice President, QA/RA, and/or other stakeholders.

* Back Room Administrator during audits in conjunction with the Back Room Manager (BRM) to ensuring the adequate control, distribution, and maintenance of records.

* Assist with Supplier Quality, including Supplier Qualifications/Disqualifications, Supplier Audits, Supplier Change Requests, Supplier Corrective Action Requests, Supplier Performance Monitoring.

* Assist with Design Quality Assurance, including serving as Quality Approver for Design Changes, Reviewing/Approving Design Verification Activities for Quality Assurance, and Initiating Change Control Requests as needed.

* Assist with Corrective/Preventive Actions (CAPA), including Containment Activities, Root-Cause Analysis, Action Items, Effectiveness Checks and CAPA Ownership.

* Assist with Risk Management and Post-Market Quality activities, including Risk Assessments, Safety Review Board, and Maintaining Risk Management Files.

* Assist with Concessions and Quality Holds as needed.

* Complete all required training applicable to assigned position.

* Exhibit positivity, flexibility, creativity, and a willingness to take on new responsibilities as requested or required.

Qualifications:

* High School Diploma or equivalent.

* Minimum three (3) years regulatory experience in the medical device industry.

* Minimum five (5) years of audit experience.

* Knowledge of FDA 21 CFR 803/806/820 and ISO 13485 Standard Regulations.

* Fulfill requirements per CP17-001 to be qualified as an Auditor/Lead Auditor

* Experience participating in a regulatory or third-party audit preferred.

* Experience investigating and implementing Corrective/Preventive Actions preferred.

* Invacare product and process knowledge preferred.

* Strong organizational and document control skills, including experience with electronic and hardcopy documents.

* Strong computer skills including use of Microsoft Office products.

* Strong attention to detail and the ability to multitask.

* Ability to work effectively in an high pressure environment.

An Equal Opportunity/Affirmative Action Employer -M/F/Disabled/Vet