DUTIES AND RESPONSIBILITES:
• Responsible for elicitation, analysis, and documentation of business requirements.
• Research and exploration of user requirements, costs, and benefits in support of documentation required for the demand management process.
• Responsible for analyzing the business needs to identify new processes and process improvements that will meet those needs.
• Documents current business processes and models to define requirements and/or gaps.
• Analyze detailed system factors including input/output requirements, information and paper flow, hardware, and software needs.
• Analyze “soft" system factors including roles, responsibilities, policy, culture, etc.
• Evaluate the impact of potential software and process changes on the organization.
• Develop and facilitate groups as necessary in pursuit of eliciting and defining requirements.
• Assist in the creation of the business case documentation.
• Understanding of architectural consistency and usability standards.
• Defines and develops user test cases and validates test results during testing.
• Executes unit and functional test cases.
• May conduct system demonstrations and training sessions, as well as participate in design/review of training content.
• Plays a third level support role by helping to troubleshoot and resolve issues with production systems.
• Participates in associate meetings and communicates any concerns to management.
QUALIFICATIONS AND REQUIREMENTS:
• Bachelor’s degree in computer science, Information Systems, Business, or another related field or equivalent work experience.
• Proven experience leading data migration requirements from legacy systems into a new ERP (Sage X3) environment
• Strong hands-on expertise in requirements elicitation, documentation, and management, with emphasis on data mapping, transformation rules, and validation
• Deep understanding of data structures, data quality, and migration best practices, with the ability to identify gaps and risks early
• Self-driven and accountable professional with strong stakeholder management and communication skills, able to drive outcomes with minimal oversight
• Working knowledge of Confluence and JIRA.
• Experience in any of the following business areas is desired: Sales operations, order entry, accounting, finance, procurement, warehouse operations, order management, and order fulfillment.
• Minimum of 3-5 years’ business analysis or systems analysis experience is preferred.
• Bonus: Sage X3 experience (ERP).
Associate is expected to operate at a proficient level across the following areas of technical knowledge and skill:
• Ability to organize and prioritize work.
• Detail oriented, proactive, creative, and efficient
• Intermediate level abilities in Excel, Outlook, PowerPoint, Visio, and Word
• Familiarity with application integration methods to include understanding of data mapping process.
• Ability to effectively work both independently and collaboratively in a team environment
• Ability to work on simultaneous and complex projects, with domain expertise in at least one business area.
• Expertise in ERP solution selection and implementation is a plus
• Ability to communicate effectively to both technical and non-technical audiences in written and non-written format
• Ability to work with all levels of associates
• Ability to work with minimal supervision in a very dynamic environment
• Ability to learn new systems and tools
• Knowledge of software development life cycle methodologies, processes, and procedures.
• Active listener
• Effective in a variety of formal/informal presentation settings: one-on-one, small, and large groups.
Job Title: Quality Engineer
Location: Pacheco, CA
Duration: 12 – 18 Months
W2 Only
- Overview
The Quality Engineer ETW (External Temporary Worker) role is responsible for BioCare/Client integration activities, including BioCare QMS certification maintenance, integration of BioCare into the Client QMS, IVDR and DHF remediation activities, inspection readiness support, and quality support for potential manufacturing and testing transfers. This role serves as an integration-focused quality resource providing governance, coordination, risk identification, remediation oversight, and escalation support to facilitate successful integration while maintaining regulatory compliance and business continuity.
The QE will support execution of the BioCare integration and IVDR plans, achievement of key milestones, quality system harmonization activities, remediation programs, and readiness actions required to sustain compliant product supply through the transition period.
- Essential Duties & Responsibilities
- Integration Quality Support for BioCare transition activities.
- Lead and coordinate quality integration workstreams and cross-functional integration projects.
- Support inspection readiness, audit preparation, and certification maintenance activities.
- Coordinate IVDR, DHF, CAPA, and QMS harmonization and remediation efforts.
- Develop and monitor integration metrics, risks, dependencies, and milestone progress.
- Maintain site metrics, responsible for site QMR and data interpretation with Sr. Leadership
- Support integration governance reviews and escalate significant quality or compliance risks.
- Confirm compliance of quality processes and documentation and establish a risk-based remediation program.
- Oversee development and implementation of relevant Quality Plans.
- Collaborate with Client Global Quality Leadership to support compliance and certification requirements.
- May also support daily operations such as general QA support, SOP review and approval, document review and approval, product logistics, batch record review, product investigations and inspection, assist in audits, coach and mentor, support NCRs, CAPAs, training, equipment qualifications, rework activities, and trending reports.
- Education and/or Experience
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
- Essential Skills
- Problem solver, root cause analysis methodology
- Process oriented mindset; data and continuous improvement orientation
- Able to work well in complex environment
- Self-starting, self-reliant, courage of convictions
- International working experience and willingness to travel globally
- Proficient in written and spoken English
- Consistently work independently, make QA decisions without requiring supervision/coaching
- Demonstrates technical understanding of manufacturing process
- Provides compliant solutions to complex problems
- Able to Coach & Mentor less experienced Professionals
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