Director of Quality Position Available In Lexington, South Carolina

Director of Quality ElectroWire Medical Lexington, SC Job Details Part-time $3,000 – $5,000 a month 11 hours ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Qualifications Management Bachelor’s degree Manufacturing Senior level Leadership 10 years Full Job Description

COMPANY DESCRIPTION

ElectroWire Medical is a cutting-edge medical device startup focused on revolutionizing catheter-based, electrosurgical access to the heart. The company is based in Lexington, SC. The job is initially part-time and will transition to full-time.

PRIMARY RESPONSIBILITIES

Responsible for coordination, documentation, maintenance, and continuous improvement of all aspects of the ElectroWire Quality System and being the Management Representative for ElectroWire. Ensures commitments and improvements related to audit findings are met. Responsible for coordination and documentation of internal and external site audits. Uses effective leadership and management skills to meet strategic quality objectives.

SCOPE OF WORK

Develop, implement, and maintain all aspects of the ElectroWire Quality Management System. Ensure sustaining support of Quality System and regulatory compliance by working on quality system issues and maintaining quality system capability. Provide Quality System/Quality Assurance support. Develop and implement process performance measures. Coordinate and lead management review discussions/presentations. Primary reviewer and assessor for all controlled document changes; responsible for assessing impact and coordinating product dispositions related to changes. Perform receiving and incoming inspection. Provide manufacturing support by addressing manufacturing process defects and implement process improvements using Quality System tools. Responsible for product release, issuance of lot Certificates of Conformance, and maintenance of LHRs for all products. Oversee day-to-day Quality work for the organization and provide guidance to ensure compliance and effective processes are maintained. Participate in identifying and incorporating new or changing curriculum and standards that affect the requirements of the Quality System. Performs other duties as assigned.

EDUCATION AND EXPERIENCE

Bachelor’s degree and a minimum of 10 years experience in a quality role in a medical device manufacturing company Advanced working knowledge of quality and regulatory procedures and practices (e.g.

ISO 13485, ISO 14971, FDA 21 CFR

Part 820, MDR, etc.) Experience with: Ensuring compliance with quality system regulations. Developing and improving work processes and resource utilization. Facilitating continuous improvement programs. Solving problems impacting work processes and personnel. Hosting audits. Conducting audits.

COMPENSATION/BENEFITS

Salary Equity Options 401(k) Health, dental, and vision benefits Paid vacation/sick leave

Job Type:

Part-time Pay:

$3,000.00 – $5,000.00 per month

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance Ability to

Commute:

Lexington, SC 29072 (Preferred) Ability to

Relocate:

Lexington, SC 29072: Relocate before starting work (Preferred)

Work Location:

In person