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Manager, Quality & Regulatory Compliance

Job Requirements::
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.
Minimum of 3 years of functional management or technical leadership experience 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 is required.
Position is located in Center Valley, PA, will consider remote candidates.
Travel is be required, approximately 50%, including international.
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, presentation skills, listening skills, interpersonal skills, negotiating skills, coaching and feedback skills, and team oriented.
Proven leadership skills in associate involvement and teamwork.
Ability to work under pressure achieving consistently high results in quality, efficiency, and compliance through individual and team efforts.
Ability to analyze complex data and integrate multi-disciplinary feedback.
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 Manager, Quality and Regulatory Compliance working on the Regulatory Compliance team, you will be empowered and inspired to do your best work. You will contribute to our mission by managing External Audits, tracking and trending compliance metrics, and leading compliance initiatives. In a typical day, you will:
Manage the external inspections and audit management for various sites, which will include site inspection/audit readiness and execution.
Ensure identified gaps or systematic risks are closed in a robust and timely manner.
Ability to lead direct and indirect resources and build and develop team.
Provide support to Internal Audits as needed.
Develop metrics and compile data on audit results, issues or trends and corrective actions and present to senior management; and develop and deliver required trainings Implement proactive compliance initiatives and provide guidance to the sites, including support for Quality improvement and remediation activities.
Establish and maintain programs that ensure the verification and monitoring of the effectiveness of the quality system and its compliance to applicable regulations and standards.
Ensure results of monitoring process are routinely communicated to management through periodic review process.
Assure all external auditing companies meet internal requirements prior to executing any portions of the contracting agreement Standardize and leverage compliance policies, practices, metrics and resources across sites.
Serve on cross-site project teams consistent with company objectives to improve overall compliance performance to established metrics and requirements.
Research emerging regulatory trends and changes in regulations and standards to incorporate into the business; 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 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 Manager, Quality & Regulatory Compliance to join us in our Center Valley, PA office. We will also consider a field based opportunity.
Let?s inspire healthier lives, together.
The Manager of Quality & Regulatory Compliance will manage External audits (i.e. FDA, Notified Bodies) for various Olympus sites, develop and deliver audit and SME training, audit preparation and orchestration. As necessary, he/she will supplement Internal Audit. The incumbent will lead the tracking and trending of compliance metrics to ensure adherence and partner with key business stakeholders to identify and implement improvements.
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.
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 Title:
Manager, Quality & Regulatory Compliance
Posting Locations:
Pennsylvania, Center Valley
Work Location:
Headquarters Gyrus ACMI, Inc
Job Family:
Quality Assurance
Auto req ID:
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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