The Senior Specialist, Quality System Engineer will ensure the West IL Quality Management System consistently meets the regulatory, enterprise and customers requirements. The Senior Specialist, Quality System Engineer will be responsible for developing and implementing continuous monitoring and improvement of the Quality Management System according to applicable regulatory requirements- MDD 93/42/EEC, Medical Device Regulation (MDR) 2017/745, 21 CFR 820, MDSAP, ISO 14971, ISO 13485 etc. and will make sure the QMS is maintained and effective . Senior Specialist, Quality System Engineer will provide support with the analysis of quality issues to identify root causes and implement corrective action to reduce risk of quality failures.
Essential Duties and Responsibilities:
The Sr. Specialist, Quality System Engineer will have an in-depth knowledge and experience of the applicable regulatory requirements and will make sure those are implemented throughout the quality management system, maintain the quality system procedures by verifying their compliance to relevant regulatory requirements, lead quality related matter regarding MDR and other regulatory requirements.
Responsible for the sites internal audit program- managing the internal audit plan as per applicable regulatory requirements, lead audits, collaborate with additional auditors, maintain the pool of auditors, review and approve audit reports, set corrective actions and perform follow ups, as well as ensure nonconformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPAs
Lead and perform risk-based approach (risk assessments) processes and implement control plans.
Responsible for site improvement projects related to Quality processes such as (but not limited to- Data integrity, Lean/Six Sigma projects, CoPQ/cost reduction, etc.).
Responsible for the QA approval of employees training files and approval of employees qualification certificates.
Responsible for the sites metrics and KPI data collection and analysis, including weekly, monthly (including MBR) and routine reports, both internally and externally. Collaborate with both internal and external stakeholders in relation to metric reporting. Identify trends in applicable areas, analyze, evaluate and initiate applicable actions to mitigate, and for presenting the data during Management Reviews
Responsible for the sites procedures alignment with applicable West Enterprise procedures.
Interact and collaborate with Laboratory; Operations, Engineering, R&D, RA, D&T and other functions to support resolution of Quality issues and investigations.
Maintaining the quality system procedures by verifying their compliance to relevant regulatory requirements.
Lead the activities to Identify and verify quality agreements with Economic Operators are up to date with the state of the art EU/US and ROW regulatory requirements along with references to the applicable SKU and distribution zones to the relevant customer/EO.
Requirements: Basic Qualifications:
B.Sc./ BA in Science. Chemistry/ Biology/ Eng. an advantage.
Minimum 5 years working in quality system/regulatory in the Medical Device/Pharma industry.
Experience with ISO 13485, ISO 14971, MDSAP, MDD and EU MDR regulations - advantage.
Experience with audits- internal, external, supplier.
Experience with customer interface and meeting customer expectations.
Excellent written and oral communication skills.
Excellent critical reading and writing skills.
Must have effective problem solving and interpersonal skills.
Ability to work independently, multi-task and thrive in fast-paced environment.
Problem solving including root cause failure analysis methods.
Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point.
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
This position is open to all candidates.
