The Director, Quality, shall establish, document, implement and maintain the integrity of the quality management system by maintaining its effectiveness in accordance with the requirements of ISO 13485:2016. The Director will be the first-line contact with all regulatory agencies and will provide guidance to the executive leadership in assurance of compliance and meet the industries best practices. The Director is responsible for regulatory compliance, training, facilitation of sponsor and regulatory audits/inspections and drives the company's quality initiatives. Manages regulatory elements of product realization schedules, personnel, resources and continuous improvement efforts to achieve efficient product creation and effective transfer of manufacturing through final product release.
ESSENTIAL JOB FUNCTIONS
- Manages, modifies, and maintains a complete and comprehensive quality system to support product development and contract manufacture of medical products and related components in various categories, including Class1 and Class2 medical devices.
- Develops the product/organizational regulatory and quality assurance strategies including registration, listings and product import from Mexico.
- Responsible for performing all duties in compliance with FDA's Quality Systems Regulations, GMPs, IS013485, AMMI Sterilization Standards, OSHA, EPA, and other international, federal, state, and local regulatory agencies.
- Assures validation and compliance of contract manufacturing and sterilization facilities.
- Evaluates and provides for audits, corrective actions, and compliance verification of internal and external quality systems.
- Manages the quality engineering function assuring that products meet their intended use through risk assessment, control plans, integrating product specification, inspection plans, continuous evaluation, and data analysis.
- Refines and implements quality product/process plans and systems.
- Ensures the implementation of systems that investigate, prepare, maintain records of, and enact effective corrective actions for customer complaints.
- Provides for systems that conduct audits of various business unit product and processes. Provides pertinent information to other personnel and departments as necessary.
- Hosts regulatory agency audits as required.
- Prepares and presents organizational performance and technical information to the management team.
- Ensures the implementation of systems to review and control documents, designs, and associated changes.
- Provides company-wide education and guidance in quality/regulatory sciences.
- Represents the company as the quality and regulatory expert internally and externally.
- Acts as or provides quality/regulatory representative on new product introduction teams.
- Assists with special projects as assigned.
- Represents or provides qualified designee as the company as the Quality Management Representative (QMR) depending upon specific sites.
*Other duties as required in support of the department and the company.
- Develops and maintains an effective organization through selection, training, compensation, and motivation of personnel. Responsibilities include planning, assisting, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Directs technical and administrative personnel engaged in quality assurance and metrology activities.
- Provides ongoing training to applicable staff to develop and encourage their technical and operational performance.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Carlisle Interconnect 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
- ASTM F--2413 rated safety toed shoes if on the factory floor
- Clear ANSI Z87.1 safety rated glasses
Carlisle Interconnect 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 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 Interconnect Technologies.
Up to 70% to Providien's various sites (California and Tijuana, MX), as well as other necessary travel.
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
Appropriate education and/or experience may be substituted on equivalent basis
- Bachelor of Science Degree in engineering, science, or related technical field with significant training and/or experience Quality & Regulatory Affairs.
- Advanced degree desirable.
- 10 plus years' experience (3-5 years in a management capacity) related to implementation of Quality/Regulatory principles, Product Development, Product sterilization, FDA: CFR, ISO 13485, ISO 14971, and CMDCAS systems/certifications. Safe Medical Devices Act including Design Control, Complaint processes, Clinical, Environmental, and Document Control systems.
- Experience in the practical application of the quality/regulatory sciences as a value-add to the organization.
CERTIFICATES, LICENSES, REGISTRATIONS
- Preferred Certified Quality Manager, Certified Quality Engineer, Regulatory Affairs Certified
- Ability to read, analyze, and interpret the most complex documents in English.
- Ability to respond effectively to the most sensitive inquires or complaints.
- Ability to write speeches and articles using original or innovative techniques or style.
- Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or associates.
- Demonstrates good judgment and decision-making skills
- Must have good supervisory experience, excellent communication, and interpersonal skills.
- Must be detail oriented, organized, and flexible.
- Math skills:
- Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
- Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
- Reasoning skills: ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Computer skills:
- Strong skills in Microsoft Office suite and Visio
- Mini-tab or similar statistical software desirable.
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 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.