DHR Reviewer-Day shift(G)

Austin, TX - USA

Monthly Salary: Not Disclosed

Posted on: 17 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Posting Start DateJob Posting End Date

Flex is the diversified manufacturing partner of choice that helps market-leading brands design build and deliver innovative products that improve the world.

A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful inclusive and collaborative environment. If you are excited about a role but dont meet every bullet point we encourage you to apply and join us to create the extraordinary.

Job Summary

Summary:

DeviceHistoryRecord Reviewer(DHR)positiontypicallyinvolvesreviewingand

ensuringcomplianceofdevicehistoryrecordswithregulatorystandardsand

internalspecifications.

SHIFT: - G - 6:00am-6:00pm Thur Fri Sat every other Wed.

Responsibilities:

Review and approve DHRs for accuracy and compliance with product specifications and traceability requirements.
Certify compliance to product specifications and traceability requirements.
Ensure proper recording of deviations and non-conformance reports from the manufacturing process.
Collaborate with cross-functional teams to request corrections to DHR documentation and improve timeliness and product quality.
Participate in quality audits and continuous improvement initiatives.
Maintain accurate and compliant records according to retention requirements. Support global facilities in meeting quality system and regulatory requirements. These roles are crucial for maintaining the integrity and safety of medical devices ensuring that all records are up-to-date and accurate.
Strong Knowledge in following and creating SOPs
Experience with FDA (Food and Drug Administration) Guidelines and Procedures.

Qualifications:

Requires a High School Diploma or equivalent technical training or equivalent experience.
Typically requires a minimum of 2 years of related experience.

What youll receive for the great work you provide:

Full range of medical dental and vision plans
Life Insurance
Short-term and Long-term Disability
Matching 401(k) Contributions
Vacation and Paid Sick Time
Tuition Reimbursement

Job Category

Quality

Is Sponsorship Available

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit qualifications and abilities. We do not discriminate based on: age race religion color sex national origin marital status sexual orientation gender identity veteran status disability pregnancy status or any other status protected by law. Were happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and well discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex you must complete the application process first).

Job Posting Start DateJob Posting End DateFlex is the diversified manufacturing partner of choice that helps market-leading brands design build and deliver innovative products that improve the world.A career at Flex offers the opportunity to make a difference and invest in your growth in a respectfu...

Job Posting Start DateJob Posting End Date

Flex is the diversified manufacturing partner of choice that helps market-leading brands design build and deliver innovative products that improve the world.

Job Summary

Summary:

DeviceHistoryRecord Reviewer(DHR)positiontypicallyinvolvesreviewingand

ensuringcomplianceofdevicehistoryrecordswithregulatorystandardsand

internalspecifications.

SHIFT: - G - 6:00am-6:00pm Thur Fri Sat every other Wed.

Responsibilities:

Review and approve DHRs for accuracy and compliance with product specifications and traceability requirements.
Certify compliance to product specifications and traceability requirements.
Ensure proper recording of deviations and non-conformance reports from the manufacturing process.
Collaborate with cross-functional teams to request corrections to DHR documentation and improve timeliness and product quality.
Participate in quality audits and continuous improvement initiatives.
Maintain accurate and compliant records according to retention requirements. Support global facilities in meeting quality system and regulatory requirements. These roles are crucial for maintaining the integrity and safety of medical devices ensuring that all records are up-to-date and accurate.
Strong Knowledge in following and creating SOPs
Experience with FDA (Food and Drug Administration) Guidelines and Procedures.

Qualifications:

Requires a High School Diploma or equivalent technical training or equivalent experience.
Typically requires a minimum of 2 years of related experience.

What youll receive for the great work you provide: