Job Description
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 prolonged 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.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.
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