Quality Compliance Specialist

vor 2 Wochen


Le Locle, Schweiz Integra LifeSciences Switzerland Sàrl Vollzeit

Quality Compliance Specialist page is loaded

Quality Compliance Specialist

Apply locations CH-xx-Le Locle-191-Facility time type Full time posted on Posted 3 Days Ago job requisition id JR-3893

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.

Responsibilities

  1. Manage complaint investigation: communication with intake service, decontamination process, complaint investigation (analysis in laboratory, dimensional analysis, physical-chemical analysis, and any other necessary tests for product investigation and cause identification), review risk files, identify root cause, DHR review, report writing, archiving, escalation to NC or CAPA when applicable.
  2. Implement and improve procedures related to complaints in accordance with applicable regulations/standards/requirements.
  3. Track Corrective/Preventive/Improvement Actions.
  4. Participate in projects related to complaints activities.
  5. Raise awareness among other departments on complaints processing.
  6. Track indicators.
  7. Apply procedures related to complaints and material vigilance.

Qualifications

  1. Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC MDD, EUMDR 2017/745, 21 CFR part 820, Chinese, Canadian, Japanese, Australian, Brazilian regulations, etc.
  2. Experience in a Medical Device manufacturing environment is preferred.
  3. Training in laboratory techniques in medical.
  4. Teamwork ability.
  5. Ability to interface with internal and external customers.
  6. Communication, organizational, negotiation and interpersonal skills.
  7. Risk management knowledge.
  8. Root cause analysis methods.
  9. Fluent in English and French.
  10. Use of Microsoft Office tools.
About Us

Changing Lives. Building Careers. Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in neurosurgery, reconstructive and general surgery, and regenerative wound care. Founded in 1989, Integra is headquartered in Princeton, New Jersey and has more than 4,000 employees worldwide. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol “IART.”

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