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Manager, Quality Documentation Control And Training

Company

Integra LifeSciences
Address , Boston
Employment type FULL_TIME
Salary
Expires 2023-12-07
Posted at 9 months ago
Job Description
Changing lives. Building Careers.

Joining us is a chance for you 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, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
The Manager, Quality Documentation Control and Training (DCT) is primarily responsible for the direction, coordination, and implementation of training for the facility in Boston. Additionally, this role is responsible for leading site wide Good Documentation Practices (GDP), documentation control standards, document storage, and record retention as defined in the Quality Management System (QMS). The DCT Manager will work closely with cross functional counterparts and Quality Leadership to support all training and documentation requirements adhering to all regulatory requirements for all geographies in which products are commercialized.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  • Lead training strategy and ensure training records are properly documented and retained.
  • Sustains QMS requirements, supports remediation efforts, and manages the budget and resource loading.
  • Reports out on project progress to senior Quality Leadership and cross functional steering committees, as appropriate.
  • Elevates a quality culture mindset with the team.
  • All other duties and responsibilities as assigned
  • May work with verbal and/or written instructions.
  • Broad knowledge of applicable regulations and standards (e.g. QSR, ISO 13485, MDD) and how to apply the principles, practices, and procedures
  • Ability and willingness to travel 10%.
  • Ensure all elements of a project are understood and delivered.
  • Coordinates with cross functional leaders in teams such as IS, R&D, Regulatory Affairs, and Operations, to ensure specific quality metrics are met.
  • Works with Quality leaders and cross functional teams to ensure good documentation practices are followed and record storage and retention adheres to regulatory requirements
  • Tracks progress, escalates obstacles, and identifies risks and mitigations with broader Quality Leadership Team.
QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for his position.
  • Education:
    • Bachelor’s degree required, preferably in a scientific or engineering discipline.
    • 5-7 years experience in people management.
    • Experience in medical product and device industry with strong concentration in QSR and ISO 13485 compliance and quality assurance preferred.
  • 5-7 years experience in people management.
  • Skills/Knowledge:
    • Ability to travel domestically and internationally as business required.
    • Experience with communicating with domestic and international regulatory bodies.
    • Strong analytical, strategic, decision making, and risk assessment abilities.
    • Organizational, leadership, and interpersonal skills.
    • Knowledge of EU MDD / MDR, MDSAP, CMDR, PMDA/PAL, APAC Country requirements, LATAM
    • Proficient in the following computer software applications: Microsoft Office
    • Exceptional interpersonal skills.
    • Strong organizational and communication skills (written and verbal).
  • Strong analytical, strategic, decision making, and risk assessment abilities.
  • Ability to travel domestically and internationally as business required.
  • Exceptional interpersonal skills.
  • Experience with communicating with domestic and international regulatory bodies.
  • Knowledge of EU MDD / MDR, MDSAP, CMDR, PMDA/PAL, APAC Country requirements, LATAM
  • Proficient in the following computer software applications: Microsoft Office
  • Bachelor’s degree required, preferably in a scientific or engineering discipline.
  • Organizational, leadership, and interpersonal skills.
  • Experience in medical product and device industry with strong concentration in QSR and ISO 13485 compliance and quality assurance preferred.
  • Strong organizational and communication skills (written and verbal).
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.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
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EOE including Disability/Protected Veterans


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
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