Systems Analyst- PLM/QMS

ATEC Spine, Inc.; Carlsbad (CA); Presencial; USD 110 000 - 125 000; Tempo integral

Resumo da oferta

Alphatec Spine, Inc. seeks a PLM Analyst to support, configure, and optimize Oracle Fusion Cloud PLM in a regulated medical device environment, ensuring integration with SAP S/4HANA, NiceLabel, and Cornerstone while maintaining FDA/ISO13485 compliance.

You will collaborate with R&D, Quality, Regulatory, Manufacturing, and IT to manage product data, engineering changes, documentation, and system integrations across the product lifecycle.

Qualificações

• Bachelor's degree in engineering, information systems, quality, or related field.
• 5-8 years of experience with Oracle Fusion Cloud PLM; Oracle Agile PLM preferred.
• Experience with QMS in a regulated medical device environment.
• Experience with SAP S/4HANA integration with PLM.
• Knowledge of FDA 21 CFR 820 and ISO 13485.
• Hands-on change control, document management, and BOM experience.
• Experience with NiceLabel and label lifecycle management.
• Medical device industry experience.
• Experience with Cornerstone LMS integrations.
• Experience with validation documentation.
• Familiarity with SAP modules (MM, PP, QM, SD).
• Audits and regulatory inspections experience.
• Strong communication and detail orientation.

Responsabilidades

• Serve as the primary administrator for Oracle Fusion Cloud PLM.
• Configure workflows, attributes, user roles, permissions, and lifecycle states.
• Maintain product structures, BOMs, specifications, drawings, and metadata.
• Support system upgrades and quarterly Fusion Cloud releases.
• Manage ECO, MCO, CR, Deviations, and change workflows.
• Ensure accurate routing, approvals, and traceability of changes.
• Maintain DHF, DMR, and technical documentation within PLM.
• Support NPI/NPD and sustaining engineering activities.
• Support QMS processes managed within PLM or integrated systems.
• Support CSV activities (IQ/OQ/PQ, evidence, traceability).
• Participate in audits related to Fusion PLM and IT systems.
• Support PLM integrations with other systems.
• Coordinate issue resolution with SAP and integration teams.
• Validate data consistency across systems.
• Provide Tier 2/3 support for PLM users.
• Create and maintain SOPs, work instructions, and training materials.
• Train users on PLM workflows, best practices, and compliance requirements.
• Support access management and role design with IT Security.
• Identify opportunities to streamline PLM and QMS processes.
• Translate business requirements into PLM specifications.

Conhecimentos

Analytical skills

Problem solving

Cross-functional communication

Attention to detail

Compliance mindset

Prioritization under pressure

System requirements translation

Formação académica

Bachelor's degree in Engineering / Information Systems / Quality

4+ years combined education/experience

5+ years Oracle Fusion Cloud PLM / Oracle Agile PLM experience

Ferramentas

Oracle Fusion Cloud PLM

Oracle Agile PLM

SAP S/4HANA integration with PLM

NiceLabel

Cornerstone LMS

Descrição da oferta de emprego

The PLM Analyst is responsible for supporting, configuring, and optimizing the Oracle Fusion Cloud PLM within a regulated medical device environment. This role ensures seamless integration between Oracle Fusion Cloud PLM, SAP S/4HANA, NiceLabel, and Cornerstone, while maintaining compliance with FDA, ISO 13485, and internal Quality Management System (QMS) requirements.

The PLM Analyst partners closely with R&D, Quality, Regulatory, Manufacturing, Supply Chain, and IT to manage product data, engineering changes, documentation, and system integrations across the product lifecycle.

Essential Duties and Responsibilities

• Serve as the primary administrator and subject-matter expert for Oracle Fusion Cloud PLM.
• Configure workflows, attributes, user roles, permissions, and lifecycle states.
• Maintain product structures, BOMs, specifications, drawings, and metadata.
• Support system upgrades, enhancements, and quarterly Fusion Cloud releases.
• Manage and support ECO, MCO, CR, Deviations, and other change workflows.
• Ensure accurate routing, approvals, and traceability of changes.
• Maintain DHF, DMR, and technical documentation within PLM.
• Support New Product Introduction (NPI/NPD) and sustaining engineering activities.
• Support QMS processes managed within PLM or integrated systems.
• Support Computer System Validation (CSV) activities (IQ/OQ/PQ, evidence, traceability).
• Participate in internal and external audits related to Fusion PLM and IT systems.
• Support and monitor Oracle Fusion Cloud PLM integrations with other systems.
• Coordinate issue resolution with SAP, middleware, and integration teams.
• Validate data consistency across systems.
• Provide Tier 2/3 support for Oracle Fusion Cloud PLM users.
• Create and maintain SOPs, work instructions, and training materials.
• Train users on Oracle Fusion Cloud PLM workflows, best practices, and compliance requirements.
• Support access management and role design in coordination with IT Security.
• Identify opportunities to streamline PLM and QMS processes.
• Partner with business stakeholders to gather, analyze, and document business requirements.
• Translate business needs into Oracle Fusion Cloud PLM requirements.

• Bachelor's degree in Engineering, Information Systems, Quality, or related field
• 5-8 years of experience working with Oracle Fusion Cloud PLM; experience with Oracle Agile PLM is preferred
• Experience supporting QMS processes in a regulated medical device environment
• Experience with SAP S/4HANA integration with PLM systems
• Knowledge of FDA 21 CFR 820, ISO 13485, and medical device regulations
• Hands-on experience with change control, document management, and BOMs
• Experience with NiceLabel and label lifecycle management
• Experience working in the Medical Device Industry
• Experience with Cornerstone LMS or learning system integrations
• Experience with validation documentation
• Familiarity with SAP modules (MM, PP, QM, SD)
• Experience supporting audits and regulatory inspections
• Strong analytical and problem-solving skills
• Excellent cross-functional communication
• High attention to detail and compliance mindset
• Ability to manage multiple priorities in a fast-paced environment
• Ability to translate business and quality requirements into system solutions
• Demonstrated ability to handle multiple assignments with attention to detail.

Education and Experience

• Minimum 4 Year / Bachelor Degree or equivalent combination of education and expereince.
• Minimum 5 years' experience in Oracle Agile PLM / Oracle Fusion Cloud PLM.
• Previous Systems Analyst experience desired

Equal Employment Opportunity & Other Disclosures

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

At this time, ATEC Spine does not sponsor employment visas for this position. Candidates must be authorized to work in the United States without the need for current or future employer sponsorship.

Salary Range

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $110,000 to $125,000 Full-Time Annual Salary