JOB SUMMARY

Oversee and manage Quality Control functions and personnel. Responsible for inspection, product disposition, holding and releasing of product, defect investigation, segregation of defective product and/or raw materials, staffing, employee issues, and updating policies and procedures at the plant location.

MAJOR RESPONSIBILITIES

Manage all performance, attendance, pay administration and employee reviews/corrective actions. Monitor and evaluate subordinate performance and make recommendations for merit increases.

Maintain a good working relationship and open communications with business partners.

Train inspectors on Quality System Regulation (QSR) and relevant company policies and procedures. Build and maintain employee morale and motivation, and ensure the team is appropriately staffed with required competencies.

Perform Line Audits to ensure acceptable product is being manufactured to specification. Conduct routine and non-routine analysis of in-process materials, raw materials, and finished goods. Investigate and resolve ongoing quality problems, such as defective raw materials and finished goods.

Develop continuous improvements and/or cost savings of existing processes and products.

Responsible for management of day-to-day activities and outcomes of a group of employees. Hire staff, recommend pay increases, perform performance reviews, train and develop staff, estimate personnel needs, assign work, meet completion dates, interpret and ensure consistent application of organizational policies.

MINIMUM JOB REQUIREMENTS

Education

High School Diploma or equivalent.

Work Experience

At least 3 years of experience working with QSR/GMP/ISO requirements and compliance or other regulated industries.

Knowledge / Skills / Abilities

Intermediate level understanding of FDA/ QSR/ ISO14551, ISO9001, ISO13485 guidelines.

Intermediate level knowledge of ANSI/ ASQCZ1.4-current revision.

Intermediate Auditing Skills.

Basic knowledge of Quality Systems Regulations and Medical Devices.

Position requires: Ability to lift up to 50 pounds; Sit, walk or stand for prolong periods of time with frequent bending and kneeling; Display specific vision abilities including, close vision, distance vision, depth perception and ability to adjust focus; Ability to work in hot and cold environments, (32F - 95F); Ability to work at extended heights.

Position requires up to 10% travel

PREFERRED JOB REQUIREMENTS

Work Experience

Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries.