SUMMARY
The Quality Manager is a crucial member of the leadership team, and a key factor in customer interactions and business success. This position is appointed as the site Quality Management Representative and leads the Quality Department to be incompliance with national and international regulatory compliance by providing quality/regulatory support for product life cycle, quality assurance and quality control functions, interacting with customers, vendors, and internal customers in order to achieve quality policy and business success. Responsible for managing the Quality department schedules, internal and external audit programs, team, resources, and continuous improvement efforts to efficiently achieve product quality requirements and global regulatory requirements. Must have excellent quality, regulatory, financial, leadership and management skills and proven experience.
ESSENTIAL JOB FUNCTIONS

• All Quality Management Representative responsibilities established in applicable local and global regulations.
• Establish Quality and reliable international standard within the organization by studying requirements and transferring to business areas.
• Establish Product Quality documentation systems by writing and facilitating Quality System procedures and policies.
• Develop, maintain and monitoring Quality Plans for QMS and Business success.
• Responsible to facilitate quality resources to achieve company goals and objectives.
• Develop a Quality structure within the organization.
• Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
• Achieves financial objectives by preparing the quality assurance budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
• Manage and host internal, external and supplier audits based on established audit program.
• Develops a quality assurance staff by recruiting, selecting, orienting, motivate and training employees.
• Manages quality assurance staff job results by coaching, counseling, and educate employees
• Contributes to team effort by accomplishing related results as needed.

• Support all programs and initiatives related to Safety, Hygiene, Environmental and Quality.
• Support all programs and initiatives related to Internal Work Policies and Organization Values.

• Others related to the organization and requested by direct supervisor.

SUPERVISOR RESPONSIBILITIES

• Develops and maintains an effective organization through selection, training, compensation, and motivation of staff. Responsibilities include planning, assisting, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Assist employees to engaged in QMS, Quality Assurance and Quality Control activities.
• Provides ongoing training to applicable staff to develop and encourage their technical and operational performance.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle or feel, and talk or hear. The employee frequently is required to reach with hands and arms. The employee is required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
WORK ENVIRONMENT
Typical office environment. The noise level in the work environment is usually quiet, and time spent on the shop floor will be subject to standard noise levels in a manufacturing environment. Carlisle Medical Technologies is a clean facility, housing different machinery, equipment, processes, and chemicals which produce potential hazards in the work environment such as: ergonomic, chemical, machine point of operation, and powered industrial vehicle traffic. These hazards are controlled through means of engineering controls, such as machine guarding, and administrative controls, such as safety policies and programs. In certain areas of the facility, employees are required to wear Personal Protective equipment such as Hearing Protection, Safety Glasses, Safety Toe Shoes, and hand protection.
PERSONAL PROTECTIVE EQUIPMENT REQUIREMENTS

• Clear ANSI Z87.1 safety rated glasses if on the factory floor
• ASTM-F2413 rated safety toed shoes.

ENVIRONMENTAL POLICY
Carlisle Medical Technologies is dedicated to identifying and reducing the environmental impact of its operations, activities, and products. It is our commitment to comply with all applicable laws and other regulatory requirements concerning the environment. We are committed to preventing pollution and continually improving our environmental performance in all of our global operations. This will be achieved through a comprehensive Environmental Management System that provides the framework for setting and reviewing environmental objectives and targets of Carlisle Medical Technologies.
TRAVEL
10-30% - mostly regional, including Mexico.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential job function satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE

• Bachelor of Chemistry, Science Degree, or related Engineering or technical field with demonstrated training and/or experience Quality & Regulatory Affairs required
• 3-5 years working in the medical device industry or thermoforming industry required.
• 1-3 years of experience in an employee management preferred.
• Good understanding of the requirements specified by the FDA QSR 820, ISO 13485, ISO 14971, OSHA, RoHs, California Proposition 65, governmental agencies, and the healthcare industry.

REQUIRED CERTIFICATES, LICENSES, REGISTRATIONS

• Lead Auditor ISO 13485 certification.
• Risk Management certification.

PREFERRED CERTIFICATES, LICENSES, REGISTRATIONS

• GD&T certification.
• A CQM
• Lean Six Sigma Black Belt certification

LANGUAGE SKILLS

• Ability to read, analyze, and interpret the most complex documents in English.
• Ability to respond effectively to the most sensitive inquires or complaints.
• Negotiation conversational skill in English.

JOB SKILLS

• Ability to negotiate internally and externally.
• Ability to work with a team and independently oriented to goals and objectives.
• Ability to work with direct reports, train and develop individuals
• Employee management experience of a Quality department (plastics manufacturing firm preferred)
• Must be detail oriented, organized, flexible, and can practically apply the quality sciences as a value-add to the organization.
• Excellent communication and written & interpersonal skills
• Good understanding of medical devices classifications and applicable regulatory requirements.
• Ability to read blueprints and have knowledge of Test Methods.
• Good understanding of all Microsoft Applications: Excel, Word, Outlook, Power BI, Team, etc.
• Working knowledge of statistical sampling plans (e.g. ISO 2859-1, C=0, ANSI Z1.4)
• Statistical Analysis software is preferred, i.e. Minitab, SPC, Measurelink, etc.

Job Type: Full-time

Pay: $115,000.00 - $130,000.00 per year

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