Quality Engineer

Quality Engineer ETW

The Quality Engineer ETW role defined here will be responsible for Biocare / client integration activities including Biocare QMS certification maintenance, integration of Biocare into Client's QMS, and Quality oversight of the defined Biocare IVDR remediation project.

The QE will provide bridging support for product quality and the site's regulatory compliance standing, supporting inspection readiness. This role will provide hands-on, on-site or hybrid, Quality direction to make visible and as needed escalate issues for broader Client team and resource engagement.

The role will also provide Quality support for potential technical transfer of manufacturing and testing from Biocare to Client site(s).

The QE will support executing Biocare integration and IVDR plan including achieving key milestones while providing quality system bridging, and readiness actions required to sustain compliant product supply through the Biocare transition.

Responsibilities

• Remediation and implementation of Quality Standards and the Client QMS per plan
• Support Site Inspection Readiness via Gemba walks when on site, promoting visibility of key issues identified during baseline, internal compliance audit through remediation.
• Monitor compliance with Registration File (and appropriate Reg Bodies)
• Confirm Product Release is done within Regulatory Standards and pertinent Registration Files.
• Confirm QC Testing, Methods, and Specifications meet Regulatory Compliance requirements and cGMPs.
• Oversee the development and implementation of relevant Quality Plans
• Develop metrics to deliver product and process improvement.
• Collaborate with Client Global Quality Leadership to support compliance and certification requirements.

Education

• Science or Engineering: BS/MS/PhD or equivalent industry experience

Experience

• Minimum 5 years working in a Quality Engineer role in a regulated industry and experience interfacing with regulatory bodies
• Strong knowledge of quality management systems, including but not limited to ISO standards, GxP, and QSR.
• Operations or Quality Experience in Medical Device Manufacturing
• FDA, and EU regulated work experiences desired
• Fluency with Six Sigma and/or Lean Manufacturing desired
• Problem solver, root cause analysis methodology
• Process oriented mindset; data and continuous improvement orientation
• Able to work well in complex environment
• Good communicator
• Self-starting, self-reliant, courage of convictions
• International working experience and willingness to travel globally
• Proficient in written and spoken English

Essential Skills

• Audit Readiness: Responsible for external audit activities, i.e., Health authorities, Notified body, Customers, and partners
• QMS: Ensuring controls and quality processes are implemented and executed during Operations.
• Client and CAPA: Assures proper handling of non-conformities and CAPA to correct and improve quality of material, products, and processes in Client Carpinteria including reworks. Monitor and drive closure of quality records including Client and CAPA, assuring a responsive organizational quality culture.
• Quality Reporting: Present and provide requested quality data from QA to Quality Management Review and KPIs.
• Validation: Assure QA oversight towards validation and qualification of equipment, systems, and processes including approval of validation plans, protocols, and reports.
• Supplier Controls: Assure supplier auditing programs are conducted and followed up on.
• Support: Provide dedicated responsibility supporting Manufacturing, assuring the right checks and controls are in place to guard product quality and quality compliance.
• Batch Records: Responsible for the review and release of DHRs.
• Batch Disposition: Releasing or rejecting product based on release criteria.

EEO Employer LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.