1809 IT & Software Developer jobs in the US

Sierra Business Solution LLC jobs

Quality Engineer - Jacksonville, FL

$96,000 - 136,000
Sierra Business Solution LLC
West Ray Road 6919, Jacksonville
$96,000 - 136,000
Company Size icon
Company Size
200-500
Company Type icon
Company Type
Services
Exp Level icon
Exp Level
Regular
Job Type icon
Job Type
Full-Time
Language icon
Language
English
Visa sponsorship icon
Visa sponsorship
No

Requirements

Must:
- Bachelors degree in Engineering or related field - Extensive experience in quality engineering, particularly in medical devices - Strong understanding of Quality Management Systems (QMS), especially ISO 13485 and 21 CFR 820 - Proficiency in risk management practices as per ISO 14971 - Excellent leadership and facilitation skills - Ability to navigate complex discussions and drive decision-making - Strong communication skills, with the ability to assertively address compliance and quality issues - Experience in cross-functional collaboration and stakeholder engagement

Technologies

Responsibilities

- Lead, moderate, and document TRB (Technical Review Board) meetings with diverse stakeholders - Conduct structured, objective discussions on technical and quality matters - Assess design intent, risks, usability, and regulatory considerations - Facilitate decision-making processes and ensure accountability for actions and risks - Review change management documentation, including ECOs, design updates, and CAPAs - Oversee risk assessments in accordance with ISO 14971 - Ensure adherence to design control and technical documentation requirements - Collaborate with subject matter experts across technical, regulatory, quality assurance, and manufacturing teams - Clearly articulate necessary changes and outline expectations - Serve as the primary liaison between change owners and review teams - Identify and mitigate gaps, bottlenecks, and inefficiencies in TRB and change management workflows - Promote continuous improvement initiatives within the team

Description


We are a leading organization based in Jacksonville, FL, focused on ensuring the highest standards in medical device quality and compliance. We offer a collaborative team environment where you will engage with cross-functional experts and contribute to significant process improvements. By joining us, youll play a pivotal role in maintaining product integrity and safety while benefiting from professional growth opportunities. We value our employees and provide comprehensive benefits that support your career and personal development.
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