Director - Design Quality Assurance - Tissue Technologies

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

• 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. 

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

·        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.

Salary Pay Range:

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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