Integra LifeSciences
Quality Compliance Specialist II - Training & Document Control
US-MA-Braintree-220-Facility · Mid
Sponsorship not specified$71k-$98kDetected 8 hours ago
Brand StrategyProcess ImprovementRecruitingFDA RegulatoryMedical DevicesCommunicationPublic SpeakingOrganizational Skills
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odds of building a lasting career here
37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level I)39
Fits your clock70
Thin sponsorship signal and lottery-bound (~15% per draw). A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
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About the role
- Thinking differently is what we do best.
- 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.
- Salary Pay Range: $71,300.00 - $97,750.00 USD Salary Our salary ranges are determined by role, level, and location.
Responsibilities
- Support administration of the site Training program, including training assignments, curricula, records, reporting, and follow-up.
- Partner with process owners and subject matter experts to ensure training content accurately reflects procedural and regulatory requirements.
- Support onboarding and role-based training for new and existing employees.
- Support training-related audit and inspection readiness, including retrieval and review of training records.
- Quality Systems / Document Control
- Support Agile document workflows, including processing and routing document and change orders.
- Provide Agile system support and assist users with document and change-control activities.
- Support document administration, data maintenance, and record management activities.
- Support Quality System metrics, data quality reviews, reporting, and process improvement initiatives.
Requirements
- Strong communication and interpersonal skills, with the ability to explain requirements clearly to employees with varying levels of experience.
- Comfort and demonstrated ability presenting information, facilitating training, and engaging groups of learners.
- Ability to work independently while collaborating effectively across functions.
- A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition.
- Bachelor's degree or equivalent combination of education and relevant experience.
- Experience in Quality Systems, Training, Document Control, or a related function within a regulated environment.
- Experience working within an electronic document management, learning management, or Quality Management System.
- Strong organizational skills and attention to detail, with the ability to manage multiple priorities and follow activities through completion.
Nice to have
- Knowledge of Quality Management System requirements, including ISO 13485 and/or FDA Quality System requirements.
- Experience administering or supporting employee training within a regulated environment.
- Experience with Agile PLM or a similar electronic document/change-control system.
- Experience supporting audit or regulatory inspection readiness.
- Demonstrated interest in process improvement and identifying more efficient ways of working.
- Additional Description for Pay Transparency:
- 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:
Compensation
- $71,300.00 - $97,750.00 USD Salary
- 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.
Benefits
- Develop, maintain, and improve training materials, presentations, job aids, and other learning resources.
- Provide backup coverage for Document Control and other Quality Systems activities as needed.
Company info
- 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.
Equal opportunity
- EEO Is the Law | EOE including Disability/Protected Veterans
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This listing is sourced directly from Integra LifeSciences's careers page and normalized into a canonical job model.