Senior QS Engineer, Global QARA Audit Support Job at Olympus Corporation of the Americas
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Job Description
Provide Quality Engineering support to ensure compliance with the Global Quality System regulatory requirements and the business strategy of the company. Represents Global QA&RA Compliance as a team member to support development and implementation Global external audit process, programs, and activities. Member of Global Audit Support Function established as a dedicated team to implement Global External Audit Process and provides all Olympus sites support for external audit related activities, improving outcomes and efficiencies. Can serve as a backup to the Director Global QA&RA Compliance, External Audit.
Job Duties
- Global QA&RA Compliance team member that supports development and implementation Global external audit process, programs, and activities. Leads or participates in the development of process and procedure development/changes.
Provides support for all Olympus external quality audits and leads/supports the development of external audit training programs, resources, and tools, improving audit execution, outcomes, and efficiencies.
Leads the development of external audit responses, facilitates completion, and delivery of responses to the US FDA, Notified Bodies, and other authorities. Supports the development and implementation of a Global audit response process.
Supports the development and implementation of new monitoring and reporting tools that measure progress of external audit schedules and audit outcomes. Identifies, accesses, and analyzes data that have impact on the company’s compliance to overall quality systems. Tracks, trends, and analyzes external audit findings, corrective actions, and remediations. Make recommendations based on areas of highest compliance risk.
Supports the development and implementation of Global audit readiness programs and tools that improve site audit readiness (compliance and audit support) and assesses likelihood of future audits.
Participant in Global External Audit Communities of Practice.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Advise management on potential improvements or enhancement to quality systems and processes in the company.
Develops new approaches to solve problems identified as part of the team. Assist in the implementation of Global QA&RA Compliance initiatives and programs throughout the Global organization.
Participates in the CAPA process as required as an assignee or project team member.
Job Requirements
REQUIRED QUALIFICATIONS:
Bachelor’s degree in Engineering discipline or equivalent
Minimum of 8 years related experience and in medical device industry.
Requires background and familiarity with applicable regulatory requirements, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA.
Experience in supporting sites / organizations through US FDA, Notified Body, and other International Regulatory Agency Audits.
Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones. Domestic and international travel up to 40 % of the time should be expected.
PREFERRED QUALIFICATIONS:
Experience writing, reviewing, and providing feedback on audit responses, is highly valued.
Interpersonal skills to develop and manage good working relationships with all Olympus locations and internal departments (R&D, Manufacturing, Supply Chain, Regulatory, Quality, Regulatory, etc…).
Ability to work effectively in a fast paced and dynamic environment.
Working knowledge of problem-solving skills good statistical and analytical skills.
Strong written and verbal communication skills.
- Proficient in the use of Information Technology.
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.
Olympus requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.
Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.
Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.
Olympus…True To You. True To Society. True To LIFE.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley ||
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