Principal Compliance Engineer

Job Description 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 Principal Compliance Engineer to join us in our Center Valley, PA office. We will also consider a field based opportunity.   Let's inspire healthier lives, together. The Principal Compliance Engineer will be responsible for the management of the Internal auditing process and assessment of the company's activities to verify quality system compliance. The incumbent will serve as auditing subject matter expert. The Principal Compliance Engineer will collaborate with business partners at Olympus to ensure compliance to all regulatory and standard requirements. Job Duties: As a Principle Compliance Engineer working on the Regulatory Compliance team, you will be empowered and inspired to do your best work. You will contribute to our mission by being the audit subject matter expert and guiding improvement initiatives. In a typical day, you will: Establish, evaluate and maintain the internal audit program that ensures quality management system are operating in compliance; develop and manage audit plans and schedule, conduct audits. Serve as an Expert on regulations and their interpretation for adequate compliance. Support the external inspections and audit management for various sites, which will include site inspection/audit readiness and execution. Coordinate and support requests for directed audits, received from senior management and other customer/business partners. Research emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements.  Lead or support special quality and compliance projects as requested, and perform other assigned duties, as needed. Perform all other other essential duties as assigned.   Job Requirements: REQUIRED QUALIFICATIONS:  Bachelor's Degree or equivalent in a technical or science-related field is required; Master's Degree or equivalent is preferred, with preferred areas of study being in the Scientific or Engineering discipline. Minimum of 7 years of professional experience in the medical device or pharmaceutical industry is required. Minimum of 5 years of auditing experience in a medical device or pharmaceutical environment is required. 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. Certified Quality Auditor (CQA) or Certified Lead Auditor are required. Ability to travel, approximately 50%; Must be willing to travel worldwide; sometimes at short notice. PREFERRED QUALIFICATIONS:  Proven leadership, teamwork, collaboration and influencing skills; demonstrated initiative and assertiveness; 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. Excellent influencing skills, communication skills, presentation skills, listening skills, interpersonal skills, manufacturing exposure, negotiating skills, coaching and feedback skills. Excellent procedure writing skills, advanced auditing techniques and Good Documentation Practices. This position is located in Center Valley, PA; but will consider remote candidates. 4531BR
Salary Range: NA
Minimum Qualification
8 - 10 years

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