Staff Quality Engineer
Staff Quality Engineer
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Job Description
What You Will Do:
Work closely with operations business functions customers sales field personnel marketing and cross-functional teams to ensure product and process quality and resolve key quality issues.
Lead and support the integration of acquired companies into existing quality systems including eQMS and ERP platforms. Act as a cross-functional liaison to ensure alignment and minimize system impacts across departments.
Collaborate with Training to develop and refine onboarding materials documentation practices and targeted training programs focused on compliance quality culture and process understanding.
Mentor and oversee NC/CAPA activities; lead problem-solving and root cause analysis efforts.
Support and lead closure of CAPAs with a focus on streamlining processes and improving system usability.
Lead quality improvement initiatives across systems processes and procedures with an emphasis on integration compliance and cross-functional alignment.
Lead quality issue investigations and provide strategic input by identifying process weaknesses and improvement opportunities.
Review and approve change management activities challenge effectiveness and drive thorough quality reviews.
Analyze KPI trends to drive continuous improvement and provide subject matter expertise in risk management.
Lead or support internal and external audits including preparation and engagement with regulatory representatives.
Support manufacturing transfers to other plants/facilities leading quality activities.
Support containment and support for potential product escapes.
Drive improvements in the electronic Quality Management System to enhance quality processes.
What You Need:
Required:
BS in a science engineering or related discipline.
4 years of quality experience in a regulated industry required.
Strong knowledge of Quality Concepts (e.g. Risk Management CAPA Audits Statistics).
Preferred:
MS CQE or CRE.
Six Sigma Green or Black belt.
Medical device industry experience is strongly preferred.
Experience in interacting with regulatory agencies (FDA MoH TUV etc.).
Understanding of US and International Medical Device Regulations.
Familiarity with ISO 13485 GDP GMP.
Proven ability to represent Quality across projects with strong communication problem-solving critical thinking and cross-functional collaboration skills in a matrix environment.
$100700 - $165100 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.
Required Experience:
Staff IC
Employment Type
Full-Time
