The Quality Leader will report directly to the VP of Operations and is responsible for the management and implementation of policies, programs, procedures, and initiatives to ensure quality standards are met. The candidate will also have a focus on ensuring that the Quality Management Systems are adequately maintained, and the company is compliant with regulatory bodies.

Responsibilities:

• Manage all activities relating to compliance with Quality Systems ISO 13485 regulations
• Lead Tekscan personnel in root cause analysis and implementation activities, ensuring that corrective actions are thoroughly investigated and corrected
• Investigate and drive process improvement by taking a proactive approach to implement preventative actions.
• Represent the Company during all audits (ISO, FDA, UL, Intertek etc.)
• Provide training, tools and techniques to ensure awareness of ISO13485 standards
• Arrange for ISO 13485 awareness training for new employees
• Plan and coordinate internal quality audits and ensure that internal audit findings and recommendations are implemented
• Ensure CAPA, nonconformance, complaint handling, recall and field actions, adverse event handling and audit programs are following current regulatory and reporting requirements
• Report to Tekscan management team on the performance of the Quality Management System based on existing quality objectives
• Work with Purchasing to establish and monitor quality requirements from external suppliers
• Engage with Product Management to ensure that Tekscan’s medical device technical files are complete and current, and any regular reviews are carried out
• Coordinate with other employees to ensure that the quality system is functioning and effective
• Coordinate registrations with relevant regulatory bodies and Authorized Representatives

Skills:

• Continuous improvement mindset
• Detail-oriented
• Excellent written and oral communication skills in English with an ability to communicate technical concepts to people with a variety of backgrounds
• Proficiency using Microsoft 365 tools, ideally with Sharepoint and MS Teams experience

Experience/Education:

• Bachelor’s Degree in Quality Management, Engineering, Business Administration or equivalent
• Minimum 3 years of leadership experience supporting ISO 13485 or similar ISO standard
• Prefer Regulatory and Compliance experience in an FDA-regulated industry
• Any additional training in Quality related fields is advantageous

Alignment With Values

• Integrity & Quality - Deliver on our commitments with product and service excellence and operate in an open, honest and trustful environment.
• Mission Driven Teamwork - We have clarity around our missions, goals and plans and respectfully hold one another to a high standard of performance.
• Innovative Applications - Experts in applying our solutions for maximum impact and embrace exploratory innovation, continuous improvement and adaptive learning.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to sit, ~50%+ of the time. The employee is occasionally required to stand; walk; use hands to fingers, handle, or feel; reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision. There may be intermittent travel requirements. No hard physical labor.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Tekscan is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, gender, religion, national origin, disability, protected veteran status, or any other legally protected characteristic.

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