Director - Design Quality Assurance - Tissue Technologies

Integra LifeSciences•Princeton, NJ

23h

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. SUMMARY The Director, Design Quality Assurance (DQA) - Tissue Technologies division has the primary responsibility to ensure the delivery of high-quality design history files (DHF) and Risk management files (RMF) that are compliant with applicable global regulations. This position has direct responsibility for design controls that focus on risk management, compliance, quality, customer requirements, and manufacturability. These activities include the development, implementation, and monitoring of quality programs and policies that ensure the development, manufacture, and distribution of medical devices in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical Affairs Law, and other applicable global regulatory agencies.

Requirements

Bachelor degree with a minimum of 15 years of experience, minimum 10 years of people management or program leadership experience. Master’s degree preferred.
Experience in the medical device design and manufacturing.
Strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education.
Significant area of expertise developed through experience and positive track record.
Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC), Japanese Pharmaceutical Affairs Law, and other national and international regulations and standards.
Experience with direct contact with FDA and EU Notified Bodies.
Knowledge of process design and implementation, change control, auditing, and document management systems.
Demonstrated organizational, management and communication skills.
Must be able to read and write in English. Must be able to demonstrate comprehension of written English by successfully completing unassisted written tests, including, but not limited to, Work Instructions and Standard Operating Procedures.
Ability to travel up to 25% or more if needed based on site needs.

Responsibilities

Directly supervises employees in the quality assurance organization.
Fulfills supervisory responsibilities in accordance with the organization’s policies and applicable laws.
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Builds high performance cultures and teams, empowering and holding direct reports and cross-functional teams accountable for successful implementation of quality assurance initiatives.
Proactively drive continuous improvement activities to ensure problems are prevented and issues resolved efficiently and economically.
Provides strategic direction and communication of the company’s goals, directives, and policies to subordinates, creating a clear vision and positive, collaborative environment resulting in the achievement of the company’s goals and increased profitability.
Drive design control standardization for the Integra Tissues Technology division and portfolio of diverse products.
Ensure that Design Assurance meets design phase gates and launches new products on time.
Drive remediation on the Design Assurance team to ensure DHF files comply with all regulations and are completed on time per plan.
Create and build confidence by establishing the design assurance function as an informed, capable, knowledgeable and accessible resource to staff, management, and stakeholders.
Leadership participation in evaluation of new product opportunities (introductions, enhancements, obsolescence).
Oversee product quality reviews, divisional management reviews and preparation of quality reports as applicable for various forums, Divisional Board Review (DBR), Plant Operational reviews etc.
Direct the activities of the Quality Department to ensure compliance with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, MDR and JPAL.
Interact and coordinate activities with other departments, external vendors, and customers.
Influences and collaborates across stakeholder groups in the areas of process / continuous improvements, identify and implement opportunities.
Perform other related duties as expected.