Are you looking for a company that cares about people's lives and health, including yours? At Olympus, we help make people's lives healthier, safer and more fulfilling, every day. We're currently looking for a Principle Complaint Management Compliance Engineer to join us in our Bartlett, TN office.
Let's inspire healthier lives, together.
The Principle Complaint Management Compliance Engineer establishes and maintains Global Relationships between Olympus Legal Manufacturers and Business Centers across Markets through Quality Assurance Agreements to ensure the proper handling of complaints and adverse events. The Principle Complaint Management Compliance Engineer governs the obligations of all Olympus entities under executed Quality Assurance Agreements through the establishment of an audit program with continual assessment to gage the level of compliance across Olympus. He/ she monitors and ensures compliance corrective actions for any deficiencies for complaint and adverse event handling are made through to closure. He/ she leads the tracking and trending of complaint handling process metrics to targets and partner with key business stakeholders to identify and implement improvements.
In a typical day, you will:
* Maintain complaint handling and adverse event Quality Assurance Agreements between Olympus Entities.
* Author new Quality Assurance Agreements to ensure compliance to Olympus complaint handling and adverse event handling.
* Revises Quality Assurance Agreements to comply with new regulations, standards, or changes to the complaint handling and adverse event business process.
* Establish and maintain complaint handling and adverse event compliance monitoring programs that ensures the effectiveness of the complaint handling and adverse event processes are being met to
applicable regulations, standards, and Quality Assurance Agreements.
* Assess Olympus business risk for all markets through evaluation of the level of compliance to Quality Assurance Agreements.
* Ensure results of compliance monitoring processes are routinely communicated to management through periodic review process.
* Monitors and ensures compliance corrective actions for any deficiencies for complaint and adverse event handling are made through to closure.
* Subject Matter Expert for Olympus relating to Complaint Handling and Adverse Event standards and regulations.
* Research emerging regulatory trends and changes in regulations and standards to incorporate into the business; ensure ongoing compliance to these requirements and inclusion into Quality Assurance
* Develop complaint handling performance metrics and compliance compile data on audit results, issues or trends.
* Monitor corrective actions and present to senior management.
* Serve on cross-site project teams consistent with company objectives to improve overall compliance performance to established metrics and requirements.
* Implement CoE proactive compliance initiatives and provide guidance to Business Centers.
* Provide support to Internal Audits as needed.
* Lead or support special quality and compliance projects as requested, and perform other assigned duties, as needed.
* Perform other duties as assigned.
* A minimum of a 4-year college degree (Bachelor's Degree) or equivalent in a technical or science-related field is required.
* Minimum 5 years of professional experience in the medical device or pharmaceutical industry is required.
* Minimum 5 years' experience performing compliance audits in a medical device or pharmaceutical environment.
* Working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, SOR 98-282 CMDR (Canada), J-PAL (Japanese), European Medical Devices Directives, European Medical Devices Regulations, ANVISA 16/2013 (Brazil), TG(MD)R Sch3 (Australia), and any other regulations or standards applicable to the site is required.
* ASQ certifications in one or more of the following areas is preferred but not required: Certified Quality Auditor (CQA), Certified Lead Auditor, Certified Manager of Quality (CQM), or Certified Supplier Quality Professional (CQIA).
* Strong project management skills; strong computer skills and use of software applications such as MS Windows, MS Office (Word, Excel, PowerPoint); strong written and oral communication skills, are required.
* Master's Degree or equivalent is preferred, with preferred areas of study being in the Scientific or Engineering discipline.
* Experience with data extraction and performance trending monitoring.
* Must be able to work independently, self-motivated, a sense of ownership with a strong sense of urgency to drive for results.
* Familiarity with establishment and maintenance of Quality Assurance Agreement content.
* Proven analytic and problem-solving skills .
* Experience in working within or with Japanese companies is desirable.
We realize work isn't just a job to you.
It's a big part of your life, but not the only part. That's why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.
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