Description

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At MicroPort, we relentlessly strive to master every detail of our medical solutions with the purpose of prolonging and reshaping the lives of patients everywhere. We welcome motivated and talented people who want to join our dynamic and inclusive company, working together to deliver meaningful medical breakthroughs. In order to accomplish this, we hold true to our core values of Quality, Integrity, Accountability, Efficiency, Innovation, Aspiration, Dedication & Collaboration. Come and join Team MicroPort!

Why You’ll Love MicroPort

You will find our team atmosphere challenging and rewarding. In addition to working with a world-class team, receiving a competitive base salary and bonus opportunities, our U.S. employees also enjoy the following benefits: Medical, Dental, Vision, Maternity Leave, Life Insurance, Short-Term Disability, Long-Term Disability, Bereavement, 401(k) (up to 4% match with vesting from day 1), PTO (Starting at 18 days each year), Paid Holidays (10 each year), Employee Assistance Program, Education Assistance...and more! At MicroPort, we care about our employees and encourage them to make healthy lifestyle choices and embrace wellness opportunities to maintain their very best health and wellbeing.

Overall Summary

As Product Release Quality Assurance Associate, you will perform documentation review to all device history, associated data, and documentations prior to releasing product. You will ensure products are not available for release until ambiguities and errors are resolved. Authorized person(s) shall issue the product release form as required and approve the release of the finished product, while remaining independent of other functions such as, but not limited to production and inspection.

Your duties will include:

• Assure inspection is performed in accordance with FDA, ISO, and other applicable regulations / guidelines.

• Follow written instructions with engineering-based content.

• Apply attention to detail in documentation.

• Interface with peers, engineers, and Regulatory auditors.

• Accurately record data results to ensure proper segregation of accepted and rejected products.

• Operate under the direction of QC Management team.

• Develop, update, and maintain Device History Record database

• Provide Certificate of Conformance (CoC) upon request

Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

About You

We might be a great match if you have:

· Ability to follow instructions, both written and oral. · Ability to work in a team environment. · Professional communication skills. · A working knowledge of basic computer skills · Ability to apply skills in a manner to ensure proper decisions for acceptance or rejection of goods is imperative. · Database management knowledge · Ability to work independently

YOUR EDUCATION

Required: High School Diploma or GED

Preferred: High School Diploma

YOUR EXPERIENCE

No related experience required

Visual acuity requirements apply to the role, including peripheral, color, and depth perception.

For internal reference, this position is a level H2.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor 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)