A world-leading medical technology company developing innovative solutions is seeking a motivated Quality Engineer to join the team as part of its global expansion. This is an opportunity to work in an innovative, fast-paced global medical device organization committed to improving patient outcomes.
The Quality Engineer oversees quality engineering, process control, and inspection efforts in support of our in-house manufacturing effort while reflecting our core values of innovation, evidence, integrity, teamwork, respect, and commitment to transplantation. This role is responsible for developing, establishing, and maintaining quality engineering and inspection programs, policies, processes, procedures, and controls enhancing the performance and quality of products and the company's capability to demonstrate conformance to established standards and agency regulations.
Responsibilities:
* Provide quality engineering body of knowledge guidance and leadership to department and organization.
* Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
* Define and implement process control & monitoring system to ensure product quality and consistency.
* Provide influential peer leadership.
* Identify quality initiatives and lead cross-functional teams to complete them.
* Assist with non-conformance and real-time data management portions of the quality system.
* Support and conduct risk assessments and failure mode and effects analysis (FMEA) to identify and mitigate potential issues.
* Act as Subject Matter Expert for area of expertise by maintaining knowledge of the relevant procedures and specifications related to current job specification, including participating in and supporting external audits e.g., BSI, FDA, etc.
* Be an effective member of cross-departmental functional teams to foster continuous quality compliance and proactive improvements.
* Maintain effective quality metrics and define and execute activities to resolve decreases in performance.
* Be a champion of Quality, Six Sigma, Lean, and disciplined problem-solving.
* Support and complete any other work-related tasks set by their manager.
Requirements:
* Bachelor’s degree within an engineering discipline or equivalent.
* Minimum 3 years’ experience working within quality at a medical device manufacturer.
* Experience with Class II or III devices.
* Expert knowledge of cGMP, 21 CFR 820, ISO 13485, 14971.
* Lead ISO 13485 certification is highly desirable.
Please reach out to or call 02033765104 for further details.
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