EDHR Reviewer Quality (Molding)

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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.

General Purpose:

SupportsElectronicDevice History Record (DHR) Reviewer in preparing and reviewing theElectronicsDevice History Records.

Job Title EDHR Reviewer (Molding)
Location Buffalo Grove IL
Work Hours 0800a-0430pm M-F

PrincipalAccountabilities:

• Responsible for review and quality release ofElectronicDevice History Record (DHR) documents and forms

• Provides guidance and assistance to support teams in development ofElectronicDevice History Record

• processes and forms

• Acts as a Subject Matter Expert forElectronicDevice History Record (DHR) processes

• Support active resolution for production issues as it relates toEDHR Completion (i.e. nonconformances

• and CAPAs)

• ReportsEDHR status to Quality Operations and Order Management teams.

• Interact with customers to completeEDHR reviews as needed.

• Support the activities to review batch records compile theEDHR and approval of in-process product and

• finished goods.

• Support final product release for medical device product

• Provides immediate quality support to the manufacturing line to document and address concerns

• Prepares graphs or charts of data or enters data into computer for analysis.

• Download quality information from quality system to be used forEDHRs.

• SupportsEDHR Reviewer for Molding

Required Experience:

• High School Diploma or equivalent technical training or equivalent experience. Typically requires a minimum of 4 years of related experience.

• Demonstrates advanced technical skills. Demonstrates detailed functional knowledge and may lead process. Has awareness of new technologies/ techniques.

• Requires the ability to utilize chartstables and specifications and operate a variety of measuring instruments. Basic understanding of typical quality tools such as 8d statistical process control FMEA and control plans. ISO/FDA Auditing experience a plus.

• Use of the following tools may be required: Office Skills: telephones data entry office software to include word processing spreadsheet and presentation package.

AW20

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

Application Deadline:

Applications for this job position will be accepted for at least five days following the job posting start date below and continuing until the end date below or until the position is filled. This posting may close sooner due to application volume.

Job Posting Start DateJob Posting End Date

The base pay range for this position is provided below. The final base rate offered will be determined using job-related non-discriminatory criteria including but not limited to experience qualifications geographic location education external market data and internal equity.

$21.61 USD - $29.18 USDHourly

Quality

Is Sponsorship Available

No

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).