Senior Quality Systems Engineer
Role details
Job location
Tech stack
Job description
Responsible for the execution of Quality Systems (QS) at legal manufacturer level, including Nonconformances (NC), Corrective and Preventive Action (CAPA), Audit Observations, Product Quality Escalation, Quality System Management Review (QSMR), regulatory submission support and other assigned QS activities to ensure systems are effective and in compliance. Manage the performance and communication of QS metrics at legal manufacturer level.
Support Regulatory activities related to internal registration, including regulatory registrations and Regulatory shipping restrictions, on-site administration of the processes to ensure all business and regulatory requirements are met.
Oversight the supplier management process on behalf of the Legal Manufacturer including but not limited to the participation to supplier verification audit and review and follow up of potential related observation, and to the management and sustaining of the legal manufacturer approved supplier list and associated critical supplier list., In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position is responsible for the following activities, * Responsible for the consistent and correct execution of QS procedures at the site to ensure the quality and compliance of processes and records for NC, CAPA, Audit Observations, Product Quality Escalation and QSMR,
- Responsible for the timely and compliant execution of site NCs, CAPA, Audit Observations, Product Quality Escalation and QSMR, by championing cross-collaboration across functions, sites, and operating companies; identifying barriers for the progress; and elevating issues for resolution,
- Manage on site the timely collection, escalation and reporting of all Quality System metrics to management
- Maintain original documentation for site NC, CAPA, Audit Observations, Product Quality Escalation and QSMR as quality records,
- Identify site needs to meet and improve system performance of NC, CAPA, Audit Observation, Product Quality Escalation and QSMR at the site level, and escalates to appropriate representative and management in a timely manner,
- Ensure quality systems are effectively deployed.
- Lead and participate in quality system improvement initiatives.
- Determine root causes of quality issues and develops corrective action and recommendations for any compliance issues for GSC base business activities
- Review process change recommendations, as appropriate.
- Establishes, maintains, and implements communications to increase awareness and promote improvement of quality issues across the business.
- Support compliance activities by participating in audit readiness; assists in Internal and External audits; serves as Subject Matter Expert for NC, CAPA processes
- Assist with external audits, generating reports with corrective action plans and ensuring implementation of corrective actions in a timely fashion
- Ensure external and internal audits preparation (strategy level)
- Create certificate of analysis process when requested
- Prepare Franchise QSMR: Ensure logistic of meeting, collect the data and information, ensure analyze of data and compliance with QSMR procedures and assist the management representative during the meeting by creating the meeting minutes and other document required per procedure.
- Ensure consistent and correct execution of change management procedures at the site to maintain the quality and compliance of the process and the records for document creation and changes
- Drive timely and compliant execution of document changes by driving cross-collaboration across functions, monitoring progress, and elevating issues in a timely manner for resolution,
- Support the Document Control process initiatives impacting the site (ei : local procedure update, document translation, cross-operating companies harmonization and process streamlining) and ensure continuity of the application of processes and systems at site level.
- Act as record coordinator, gatekeeper or Record Manager backup depending of the needs of the company (but cannot be all together for the same request)
Oversight of supplier management on behalf of the legal manufacturer:
- Participate to supplier verification audit to represent the LM,
- Review and follow up any supplier open observation,
- Support the supplier quality team to provide Legal manufacturing information for pre-audit preparation steps,
- Manage and sustain the Legal Manufacturer Approved Supplier List for Medos International Sarl.
- Manage and sustain the Critical supplier list of Medos International Sarl,
- Support compliance activities by participating in audit readiness; assist in Internal and External audits; serve as Subject Matter Expert for Legal Manufacture purchasing control processes.
Invoice management (as Backup when needed):
- Creation and management of purchase orders
- Support for the follow-up of purchase orders in the system ARIBA/ EMARKET PLACE
Regulatory support (as Backup when needed):
Ensures consistent and correct execution of Quality System - Regulatory procedures at the site to maintain the quality and compliance of the processes and the records of regulatory documentation provision. This includes:
- Coordinate regulatory shipping restrictions process and quality restrictions
- Review related procedures
Responsible for communicating business related issues or opportunities to next management level
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
Requirements
Do you have experience in Quality assurance?, Do you have a Bachelor's degree?, University/Bachelor's Degree or Equivalent, * Knowledge / experience of medical or technical industry
- 4 to 5 years of professional work experience within a quality assurance or compliance audit environment is required. Experience working in a Medical Device manufacturing environment is preferred.
- Prior experience of External Regulatory and/or Notified Body Inspections (e.g. FDA, BSi etc) is preferred., Analytical Reasoning, Business Alignment, Business Behavior, Coaching, Collaborating, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People
