Job Information
Integra LifeSciences Manager, Quality Documentation Control and Training in Boston, Massachusetts
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.
The Documentation Control & Training (DCT) Manager 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.
Elevates a quality culture mindset with the team.
Works with Quality leaders and cross functional teams to ensure good documentation practices are followed and record storage and retention adheres to regulatory requirements.
Sustains QMS requirements, supports remediation efforts, and manages the budget and resource loading.
Lead training strategy and ensure training records are properly documented and retained.
Ensure all elements of a project are understood and delivered.
Tracks progress, escalates obstacles, and identifies risks and mitigations with broader Quality Leadership Team.
Broad knowledge of applicable regulations and standards (e.g. QSR, ISO 13485, MDD) and how to apply the principles, practices, and procedures.
Coordinates with cross functional leaders in teams such as IS, R&D, Regulatory Affairs, and Operations, to ensure specific quality metrics are met.
Reports out on project progress to senior Quality Leadership and cross functional steering committees, as appropriate.
May work with verbal and/or written instructions.
Ability and willingness to travel 10%.
All other duties and responsibilities as assigned.
DESIRED MINIMUM QUALIFICATIONS:
The requirements listed below are representative of the knowledge, skill and/or ability required for his position.
Education:
Bachelor's degree, preferably in a scientific or engineering discipline.
10 yrs relevant experience may be considered in lieu of a degree.
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.
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).
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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