Quality Systems Director

WHAT IS TEKNIPLEX?

TekniPlex Healthcare leverages its world-class materials science knowledge to deliver better patient outcomes by designing and manufacturing products that allow for less invasive procedures, reduce pain, enable faster healing and safer drug delivery.

We harness the power of world-class materials scientists, a global network of application-specific engineers, and healthcare technical teams to provide today’s finest materials solutions.

We work in a collaborative and consultative way with our customers to develop the ideal material solution to optimize mechanical properties and chemical composition to achieve the desired product performance. We are currently hiring a Quality Systems Director for our MedTech Solutions business. This role is remote.

JOB SUMMARY

The Quality Systems Director will lead the development and establishment of an enterprise Quality System within the TekniPlex Med-Tech Solutions (MTS) business. The enterprise Quality system will be aligned with regulatory requirements, incorporate customer needs and provide the business with robust Quality processes that support the growth of the business.

DUTIES AND RESPONSIBILITIES

• Lead the design and development of the enterprise Quality system, ensuring alignment with Regulatory requirements and customer needs.
• Establish and lead cross functional teams across the business to achieve appropriate collaboration and SME input required for the successful development of the Quality system.
• Leveraging EQMS capabilities, design and implement functions workflows that facilitate user adoption and support compliance.
• Develop and execute a comprehensive strategy that will ensure the effective deployment of the Quality processes across the business, with emphasis on creation of training material and the provision of training.
• Support, coach and assist the manufacturing organization to facilitate the adoption of the Quality system post deployment.
• Establish governance structures for overall delivery of the QMS program, provide timely updates to the Leadership team and sites management regarding planning and execution.
• Establish Key Performance Indicators (KPI’s) to ensure the overall effectiveness of the Quality System is monitored and continuous improvements are identified.
• Promote the Quality culture required within the business to aid compliance with international standards and deepen the understanding of Medical Device and Pharmaceutical customer needs.

REQUIRED QUALIFICATIONS

• Bachelor’s degree with at least 10 years industry experience leading Quality Management system and proven ability in the development of Quality processes.
• Strong understanding of regulated industry, specifically ISO 13485, ISO 14971 and FDA 21 CFR 820.
• Effective communication and report writing skills.
• Strong negotiation skills with customer-oriented attitude.
• Excellent analytical ability to grasp the key points from complicated details.
• Good leadership capabilities to lead project to successful completion.
• Familiarity with tools, concepts and methodologies of quality management.
• Ability to travel approximately 10-20% (including international travel).

Salary range for the role is $154,000 to $231,600 per year.

LANGUAGE SKILLS

Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.  Ability to write routine reports and legibly complete time cards and work orders.  Ability to read, analyze, and interpret technical procedures and read blueprints and technical drawings, such as machine, mechanical, pneumatic, hydraulic, and electrical.  Ability to effectively present information in one-on-one and small groups situations to other employees of the organization.  Ability to effective present information and respond to questions form groups of managers, clients, customers, and the general public.

MATHEMATICAL SKILLS

Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.  Ability to compute rate, ratio, and percent.  Ability to apply concepts of basic algebra, geometry, fractions, percentages, ratios, and proportions to practical situations.

REASONING ABILITY

Ability to solve practical problems and deal with a variety of variable in situations where only limited standardization exists.  Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.  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.

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 will 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 stand, walk, and talk or hear.  The employee frequently is required to use hands to finger, handle, or feel and reach with hands and arms.  The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell.  The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 50 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

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and vibration.  The employee is occasionally exposed to high, precarious places; fumes or airborne particles; toxic, flammable or caustic chemicals; outside weather conditions; and extreme heat.  The noise level in the work environment is usually moderate

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Equal Opportunity Company

Tekniplex is proud to be an Equal Opportunity Employer. Our hiring practices provide equal opportunity for employment without regard to race, religion, color, sex, gender, national origin, age, United States military veteran’s status, ancestry, sexual orientation, marital status, family structure, medical condition including genetic characteristics or information, veteran status, or mental or physical disability so long as the essential functions of the job can be performed with or without reasonable accommodation, or any other protected category under federal, state, or local law.