Careers in Quality

Excellent opportunity with medical device manufacturrer in Clearwater, FL.

Assist in the design and implementation of policies and procedures to insure quality standards are met during production, that company products meet customer expectations and achieve superior reliability while maintaining compliance with Federal, State and other regulations and standards governing the medical device industry, including but not limited to FDA, ISO, UL, OSHA, EPA, ASTM, ANSI.

Snapshot of Duties (not all inclusive):

• Assist with the management and submission of recalls/FSN’s and adverse event reports.
• Prepare monthly quality trending reports.
• Coordinate and process nonconformance reports - e.g., log, investigate.
• Coordinate re-work of products as necessitated by quality requirements.
• Log and manage supplier corrective actions needed (SCARs)
• Coordinate/Manage the calibration of inspection and testing equipment.
• Perform supplier evaluations and monitor supplier performance.
• Manage the external standards indexes.
• Assist with external/quality audits by customers and regulatory authorities.
• Log and manage corrective action/preventative action (CAPA) plans.
• Creation of product labels for manufacturing.
• Participate and provide support/guidance for change orders.
• Assist International requests for information for product registrations.
• Assist with regulatory functions as needed

Mercury Medical is in business 50+ years, is privately held, provides competitive benefits (health, dental, vision, life, disability, 401k with match, paid time off). Corporate headquarters and manufacturing in Clearwater, FL.

Mercury Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

https://www.mercurymed.com

Qualifications:

• The successful candidate will have possess a Bachelor’s Degree, preferably in Engineering, Life Sciences or related field.
• Experience with FDA QSR and ISO 13485 QMS requirements.
• Minimum of 7 years-experience in medical device quality compliance.
• Experience with Class I and II medical devices strongly preferred.
• ASQ CQE/CQA certification is a plus.
• Knowledge of Database software; Spreadsheet software and Word Processing software.
• Excellent communication skills, both written and verbal.