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Senior Quality Assurance Analyst (Medical Compliance)

  • Minsk, Belarus
  • hot
Job #: 45214
Currently we are looking for a Senior Quality Assurance Analyst (Medical standards) for our Minsk office or Kiev office to make the team even stronger.

The successful candidate will join a team that designs, maintains and operates Quality Management System (QMS) for medical devices, which covers Hardware and Software medical devices. You will be managing global QMS processes for medical devices and implementing QMS for medical devices requirements in particular locations or projects.

Responsibilities

  • Study company rules, QMS for medical devices compliance approaches and procedures
  • Develop internal processes and policies for QMS for medical devices
  • Expand existing QMS for medical devices with new standards and regulations
  • Facilitate company teams and locations for internal and external audits independently
  • Conduct internal trainings in compliance area
  • Perform internal audits independently
  • Manage and/or assist customer or company QMS compliance requirements implementation
  • Support Sales teams with customer’s questions and audits in Medical compliance area
  • Implement the following standards: ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, parts of FDA and cGMP, customer’s medical requirements

Requirements

  • Several years’ experience working with QMS for medical devices. Working with Hardware medical devices is preferable
  • Experience with implementation or support or audit of QMS for medical devices or substantial set of processes related to QMS for medical devices
  • Strong knowledge/experience in any of the following frameworks: ISO 13485 or FDA requirements for medical device manufactures
  • Knowledge of/experience in any of the following standards: ISO 9001, 14971, 62304, IEC 62366-1, FDA/CFR parts, cGMP parts, etc
  • English B2 or higher
  • Good communication skills (readiness to communicate with people in multinational environment, ability to communicate orally and in writing explaining tasks, documentation, companies requirements)
  • Ready to learn including self-learning
  • Willingness to work in compliance area playing with big amount of policies, evidences and reports

Nice to have

  • Experience in development and performance of compliance program for Medical device manufacturer (gap analysis -> remediation plans -> detailing tasks, managing of tasks implementation -> internal audit)
  • Experience in Medical compliance audits
  • Certificates in Medical compliance area (ISO 13485, FDA, etc.)
  • English B2+ or higher

We offer

  • Innovative solutions delivery to the world’s digital changes
  • Experience exchange with colleagues all around the world
  • Opportunities for self-realization
  • Friendly team and enjoyable working environment
  • Engineering, corporate and social events
  • Social package: professional & soft skills trainings, medical & family care programs, sports
  • Free English classes
  • Flexible working schedule
Learn more about EPAM in Belarus

Equal Employment Opportunity

EPAM Systems, Inc. is an equal opportunity employer.  We recognize the value of diversity and inclusion in creating success for our customers, business partners, shareholders, employees and communities. We are committed to recruiting, hiring, developing and promoting employees without discrimination. As a global employer, this commitment includes complying with all laws in the countries in which we operate. Nevertheless, we believe equal employment practices should not be limited to what the law requires. Equal opportunity and inclusion are essential to motivate, empower and recognize the best in everyone.

At EPAM, employment actions are based on individual qualifications, without regard to race, color, religion, creed, gender, pregnancy status, sexual orientation, gender identity, gender expression, marital or familial status, national origin, ancestry, genetics, age, disability status, veteran status, citizenship status when otherwise legally able to work, or any other characteristic protected by law.

Pay Transparency Non-Discrimination Provision

EPAM will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Affirmative Action Obligations as a U.S. Government Federal Contractor

As a U.S. federal government contractor, EPAM is committed to meet its affirmative action obligations to make good faith efforts to expand the recruiting pool of women, minorities, individuals with disabilities, and protected veterans through outreach, targeted recruitment, training opportunities and other activities. We affirm this commitment annually in EPAM’s Affirmative Action Plans. The full text of our Affirmative Action Plan for Persons with a Disability and Protected Veterans is available for inspection in the People Operations Department during normal business hours. Email the People Operations Department to schedule an appointment.

Accessibility for Applicants with Disabilities

EPAM is committed to working with and providing reasonable accommodation to individuals with disabilities. If you require an accommodation at any stage of the employment application process, please send an email to the People Operations Department including your name, a detailed description of your requested accommodation, and the best method to contact you. If you have already reviewed a job posting or submitted an application for a job, please include the requisition number. We will assist you and make a determination on your accommodation request on a case-by-case basis.

EEO is the Law. Applicants to and employees of EPAM Systems Inc., are protected under Federal law from discrimination.

EPAM Systems, Inc. participates in eVerify.

Background investigations are required for all new hires as a condition of employment, after the job offer is made. Employment will not begin until EPAM Systems receives and approves the results of the background check.

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