Tekni-Plex Healthcare partners with customers to deliver patient care solutions that make the world a healthier place through a shared vision to deliver better patient outcomes, faster healing with less pain, in a safe and efficient way for both patients and clinicians. The Director of Quality will be responsible for ensuring compliance, driving standardization, and supporting the Healthcare quality strategy and goals.
RESPONSIBILITIES
As a member of the eXtended Leadership Team (XLT), this individual will work in a cross-functional peer group to take ownership and accountability for the execution of the applicable product group strategy and help TekniPlex Healthcare achieve short and long-term goals.
Responsible for the establishment, implementation and maintenance of the quality management system to ensure compliance to regulations, standards, and customer requirements for sites within the Healthcare division
Plan and direct the implementation of standardized quality processes within the Healthcare division
Ensure the quality requirements are recognized, understood, and maintained across the company.
Monitor changes to quality regulations, guidelines, and standards, advising the leadership team of any business implications of these changes.
Make recommendations for corrective and preventive actions necessary to ensure conformity with regulations, standards, and customer requirements.
Ability to identify and resolve problems in a timely manner and gather and analyze data skillfully
Coordinate the implementation of standardized quality management system software across barrier solutions sites
Work cross functionally in the development of and adherence to quality related KPIs
Alongside sales and customer service, organize the trending and use of customer feedback, including scorecards and surveys
Participate in and provide guidance for the product development process
Provide input into annual budgeting exercises
Ensures actions taken towards the quality strategy support Tekni-Plex Healthcare’s overall strategy and goals
Communicates status updates regularly to business leadership and other senior leadership
Will uphold the Tekni-Plex 6 Commitments:
BE SAFE: Maintain a safe working environment
EMPOWER PEOPLE: Attract, Embrace, and Empower People
ACCELERATE INNOVATION: Transform ideas into action
OPTIMIZE OUR WORK: Simplify the organization and processes
Directly supervises Quality leaders at the applicable Healthcare sites. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, training employees, planning, assigning, appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
QUALIFICATIONS (mandatory):
Education: Bachelor’s Degree in quality, business, engineering or a technical discipline
Experience:
Ten (10) or more year’s full-time quality assurance experience, with three (3) or more years of that being in flexible packaging, medical device, pharma, or equivalent
Experience with ISO 9001, ISO 15378, ISO 13485, ISO 22716 or related quality registration
Knowledge of FDA requirements (21 CFR, medical device and pharmaceutical product qualification and registration, DMF registration and management) preferred
Managerial experience required
Customer-facing roles within the Quality function
Skill: Excellent interpersonal communication, verbally and in writing, with a diverse range of people; analyzing and independently solving a variety of difficult situations and problems; occasionally working long irregular hours under pressure.
We offer a full complement of valuable Health, Wellness, and Welfare benefits which include:
PTO & 8 Company Holidays
Medical, Dental, and Vision.
Life and Disability.
401(k) and Match.
Wellness Program including EAP.
Pay for Performance philosophy.
Medical benefits are effective on the first day of the month after being hired
