Job Description
Job Title: Quality Engineer
Job Type: Permanent
Location: Oxford, UK
A world-leading medical technology company developing innovative solutions are 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 organisation committed to improving patient outcomes.
TThe 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 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. To include 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 disciple or equivalent
* Minimum 3 years’ experience working within quality at a medical device manufacture
* Experience with Class II or III devices
* Expert knowledge cGMP, 21 CFR 820, ISO13485, 14971
* Lead ISO13485 certification is highly desirable
Please reach out to Emily.james@skillsalliance.com or call 02033765104 for further details.