Quality Manager

POSITION OVERVIEW: The Quality Manager is primary responsible for the day-to-day Quality operations at the Georgia facilities. The Quality Manager is responsible for ensuring that all product shipping to customers meets customer requirements and all internal policies and procedures are followed.

JOB RESPONSIBILITIES:

• Lead, coach and develop all personnel within the Quality team to continually improve quality performance, and manufacturing efficiency.
• Proactively evaluates existing and emerging quality requirements and directs implementation of activities to assure compliance to ISO, and FDA.
• Lead the maintenance and enhancement of the overall Quality Management System (QMS)
• Oversee Supplier Management Program, including distributors
• Ensure internal audits are completed, be a part of the internal audit team, conducts audits
• Assist in maintaining quality metrics appropriate for Management Review and Monthly Metric reviews
• Maintain systems and documentation required for the maintenance of a 21 CFR Part 820 total quality system and compliance to applicable International standards, such as ISO 13485 as required.
• Lead QMS programs (SCAR, NC, CAPA, Complaints), initiate and direct corrective actions to problems relating to product or process quality, such as complaint resolution, customer interface, regulatory action.

• This position requires travel to a sister site close by
• Other duties as assigned

QUALIFICATIONS:

• Degree in business, science, or engineering and minimum 3 years prior experience in a leadership Quality Assurance role for a regulated industry: Medical Device, Pharma, 3PL, Food.

OR

• 5 years’ minimum leadership experience in Quality Assurance in Medical Device, Pharma, 3PL.

Additional Employment Qualifications:

• Experience working with contract manufacturers, suppliers, or distributors.
• Exceptional written and oral communication skills.
• Track record of improving processes and goal achievement
• Proficiency in Microsoft Office.
• Experience with ISO and FDA regulations
• Experience in quality management systems.
• Experience in quality system audits.
• Desire to own decisions and take responsibility for outcomes.
• Willingness to continually embrace personal and professional development

• All prospective employees must pass a background and drug check.

DISCLAIMER

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Representations and Warranties of Employee.

Employee hereby represents and warrants to the Company as follows: (i) Employee has the legal capacity and unrestricted right to perform the job duties and obligations hereunder; (ii) the acceptance of this position by Employee and the performance of his or her obligations hereunder will not violate or be in conflict with any fiduciary or other duty, instrument, agreement, document, arrangement or other understanding to which Employee is a party or by which he is or may be bound or subject; and (iii) Employee is not a party to any instrument, agreement, document, arrangement or other understanding with any person (other than the Company) requiring or restricting the use or disclosure of any confidential information or the provision of any employment, consulting or other services.

I have read and understand the job description as outlined above.