CAPA/QMS Quality Engineer (On-Site)

Please note that this is a 12-18 Month Contract and is On-Site.

JOB DESCRIPTION:

Education:

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

Required 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 experience desired

· Fluency with Six Sigma and/or Lean Manufacturing desired

· Problem solver with root cause analysis methodology experience

· Process-oriented mindset with data and continuous improvement orientation

· Able to work well in a complex environment

· Good communicator

· Self-starting, self-reliant, and able to demonstrate 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, including health authorities, notified bodies, customers, and partners

· QMS: Ensuring controls and quality processes are implemented and executed during operations

· NCR and CAPA: Assures proper handling of non-conformities and CAPA to correct and improve quality of materials, products, and processes, including rework. Monitor and drive closure of quality records including NCR 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 toward 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 support to Manufacturing, assuring the right checks and controls are in place to maintain 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

Required Skills:

· General QA support

· SOP Review & Approval

· Document Review & Approval

· Product Logistics

· Batch Record Review

· Product Retain Inspection/Management

· Participate on Project Teams

· Meet or exceed company Values and Behaviors expectations

· Product Disposition (RM & FP where applicable)

· Batch Record & Label Issuance

· Support Inspections

· Assist in Internal/External Audits

· Coach & Mentor less experienced professionals

· Pest Control Management

· Initiate & Approve Non-conformances

· Initiate, Review, and Approve CAPAs

· CAL and PM Program Record Review

· Qualified Trainer

· Review & Approve QC Investigations

· Review & Approve Equipment Qualifications

· Review and Approve Rework activities

· Maintain site metrics

· Consistently work independently and make QA decisions without requiring supervision or coaching

· Demonstrate technical understanding of manufacturing processes

· Provide compliant solutions to complex problems

· CC Review/Approval

· Approve Trending Reports

· Responsible for site QMR and data interpretation with Senior Leadership

· Lead Project Teams

· Remediation and implementation of Quality Standards and the company QMS per plan

· Support Site Inspection Readiness via Gemba walks when on site, promoting visibility of key issues identified during baseline and internal compliance audits through remediation

· Monitor compliance with Registration Files and appropriate regulatory bodies

· Confirm Product Release is completed 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 Global Quality Leadership to support compliance and certification requirements

Description:

The Quality Engineer will be responsible for supporting integration activities, including Quality Management System (QMS) certification maintenance, integration into the company’s QMS, and Quality oversight of IVDR remediation activities.

The Quality Engineer will provide Quality support for product quality, regulatory compliance, and inspection readiness. This role will provide hands-on, on-site or hybrid Quality direction, identify and escalate quality issues as needed, and coordinate with cross-functional teams and resources.

The role will also provide Quality support for potential technical transfer of manufacturing and testing activities between sites.

The Quality Engineer will support the execution of integration and IVDR plans, including achievement of key milestones, quality system bridging, and readiness activities required to sustain compliant product supply throughout the transition.

Candidates must provide their phone number. Job reference number is A5490.