Be an early applicantLess than 25 applicants

Company

Baebies · 20 hours ago

Senior Quality Assurance Engineer

Durham, NC

Full-time

Onsite

Mid, Senior Level

$80K/yr - $120K/yr

7+ years exp

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HospitalMedical

Work & Life Balance

H1B Sponsor Likely

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Responsibilities

Ensure FDA,IVDD, IVDR, ISO 13485 compliance

Conduct internal audits and manage external audits

Assist in the management of the corrective and preventive action system, initiate, track, close, review and maintain logs and metrics

Administration of non-conforming material and deviation processes

Support document control administration, including review and routing of change orders, filing records, and training need employee on the use of Unipoint and Arena systems.

Pre-Market Quality Assurance (Design and Process Documentation Review)

Provide support for equipment and process validation

Manage risk management process throughout product life cycle

Compile, analyze, trend and present QMS metrics

Gather and prepare data for quality meetings and management review meetings

Work closely with Regulatory to ensure labeling meets international regulatory requirements

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

FDA complianceISO 13485 complianceInternal auditsQuality AssuranceStatistical data analysisSoftware validationMedical device industry experienceRegulatory requirements interpretationTechnical writingProject management

Required

BS in engineering or life science field.

7+ years' experience in Quality Assurance in the medical device industry

5+ years' experience with FDA and ISO 13485 quality systems regulations and guidelines.

Performance of Internal audits

Product and process related validation

Design and development process and DHF requirements

Software validation activities for medical devices

Strong statistical data analysis knowledge

Read, interpret, understand, and implement regulations and regulatory requirements

Technical writing, including reports, and protocols

Excellent verbal and written communication skills

Ability to work with all levels of an organization

Project management

Work independently with minimal supervision

Preferred

Experience in small to medium size medical company

Benefits

100% employee premiums for Medical & Vision coverage

100% employee and family premiums for Dental coverage

401K available

Stock Options

4 Weeks PTO

14 Paid Holidays per year

Paid Employee Life Insurance

Onsite free gym membership & classes

Discount Pet & Legal Insurance

Fertility & Family Support

Company

Baebies

Baebies develops early disease detection and comprehensive diagnostic solutions.

Founded in 2014

Durham, North Carolina, USA

51-200 employees

http://baebies.com

H1B Sponsorship

Baebies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (2)

2022 (1)

2021 (2)

2020 (1)