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Principal Compliance Engineer

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.
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.
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 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.
About Us:
At Olympus, we put a lot of good back into the world, and what we do really matters. We are committed to making people?s lives healthier, safer and more fulfilling every day by crafting innovative optical and digital solutions in medical technologies, microscopy, industrial solutions, cameras, and audio recorders.
We view our relationship with and commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our vision, and everyone here helps to make it a reality. We?re invested in our employees, great ideas, and how they impact the communities around us. We see the world through multiple lenses and come together to find the right answers; the best solutions.
THAT?S OLYMPUS.
TRUE TO YOU. TRUE TO SOCIETY. TRUE TO LIFE.
Olympus Surgical Technology America
Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled
Company URL:
Olympus Surgical Technology America at http://www.olympus-osta.com/
Posting Locations:
Pennsylvania, Center Valley
Work Location:
Headquarters Gyrus ACMI, Inc
Posting Title:
Principal Compliance Engineer
Job Family:
Quality Assurance
Auto req ID:
4531BR
4531BR
Olympus is an Equal Opportunity Employer, and our policies prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.

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