Director, Quality Assurance

Full Time Boston MA Integra LifeSciences

Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.

Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we’ve evolved into one of the world’s leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.

But that’s just the beginning. Integra is growing at an unprecedented rate. We’re at a moment in time where the experience you’ll gain is more robust than the experience you bring. And we’re out to invest in your future because it’s the best way to maximize ours.

At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra’s ongoing commitment to our values and our shared success.

Integra’s health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both.

Regardless of geographic location, our commitment is to offer the following, whenever possible:

  • Benefit plans that meet all local statutory requirements
  • A range of programs that reflect typical local market practices
  • An opportunity for employees to tailor benefits to their specific needs
  • Benefits that balance employee’s short-term and long-term needs

Click HERE for more information regarding our benefits and total rewards program

SUMMARY DESCRIPTION

Manages all aspects of Integra LifeSciences-Boston product quality and ensures compliance with global regulatory and company requirements. Responsible for managing the development, implementation and maintenance of quality assurance systems and activities at Integra Life Sciences (ILS) – Boston in accordance with applicable global regulations.  Manages all personnel and activities of Quality Operations for ILS-Boston.  Partners with Plant Manager and other site functional leaders to optimize operational excellence for the site and ensure ongoing product and process quality.

 

SUPERVISION RECEIVED

Under direct supervision of the VP of Quality Assurance – OTT.  Normally receives no instruction on routine work, general instruction on new assignments.

 

SUPERVISION EXERCISED

Manages through subordinate supervisors or managers, all ILS-Boston Quality Assurance activity with responsibility for results in terms of decisions, costs, methods and employees.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

 

  • Serves as Quality Management Representative and who is also the Person Responsible for Regulatory Compliance for the Integra LifeSciences-Boston site. This responsibility includes serving as primary interface with external auditors.
  • Leads site Quality Leadership Team.
  • Ensures that the Quality Management System is established, implemented and maintains its effectiveness in accordance with applicable global regulations.
  • Ensures customer and regulatory requirements are determined and met.
  • Directs the Quality Operations function to assure that all products manufactured meet customer, corporate, quality and regulatory requirements.
  • Ensures CAPA and CAPA subsystems are implemented effectively and result in timely actions to address identified product or process issues.
  • Maintains an expertise in FDA/QSRs, ISO 13485/MDD/EUMDR, MDSAP, Canadian Medical Devices Regulations (CMDR) and other international requirements.
  • Leads cross-functional Quality Leadership Team focused on overall site compliance and improvement.
  • Oversees and directs personnel and activities for all, but not limited to the following key areas of Quality Operations:
    • Quality Engineering (including Design and Process change review/approvals)
    • Inspection and Test (QC)
    • Complaint Investigations
    • Document Control and Records Controls
    • Internal Auditing
    • CAPA program
    • Control of Nonconforming Product
    • Product Holds
    • Site Readiness and Hosting of External Audits/Inspections
    • Quality Management Reviews
    • Quality Metrics
    • Employee Quality Training
  • Develops and implements budgets and organizational structures that are efficient and effective in supporting the above activities. Manages the department within budget.

DESIRED MINIMUM QUALIFICATIONS

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

 

Education & Experience:

  • Bachelor’s or Master’s degree in Quality Assurance, Life Sciences, or Engineering

and a minimum of ten (10) years of experience in the Medical Device Industry.

  • Minimum of seven (7) years in Quality Operations in manufacturing environment.
  • Minimum of five (5) years personnel management and mentoring experience.
  • Demonstrated experience in successfully leading a team.
  • Demonstrated experience in project management and leading cross-functional teams.
  • Expert knowledge and application experience in all aspects of Quality Management System in alignment with applicable medical device global regulations.
  • Extensive expertise with External Regulatory Agencies during audits/inspections (e.g., Notified Bodies and FDA).
  • Experience with CAPA processes including investigational techniques.
  • Experience with Risk Management regulations and application (ISO14971).
  • Strong technical aptitude (i.e., ability to read, interpret and apply regulations, ability to read and comprehend technical documentation, ability to comprehend and execute procedures)
  • Experience with development and implementation of quality system procedures.
  • Auditor Certification preferred.
  • Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner.
  • Ability to communicate effectively (both written and oral) using English (or local language).
  • Ability to influence positive change effectively.
  • Exceptional conflict-resolution skills.

 

TOOLS AND EQUIPMENT USED

Ability to utilize a computer, telephone, smart phone (Blackberry) as well as other general office equipment.  Strong computer skills are required.

 

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required of position in order to successfully undertake the essential duties and responsibilities of this position.  In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

 

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility.  The employee may be required to periodically lift and/or move up to 20 lbs.  Must be capable of using a keyboard for computer purposes.

To apply for this job please visit topspotjobs.com.