Fresenius Medical Care North America Supplier Quality Engineer II in Waltham, Massachusetts
PURPOSE AND SCOPE:
Responsible for End-to-End quality and sustainability with allocated supply base, validate and release components, and supports the definition and implementation of supplier quality functional excellence initiatives. Ensures the company receives top quality product and service at all times. Investigates root cause and makes recommendations on how to proceed with suppliers who do not meet that requirement.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Interfaces directly with suppliers to follow up on quality and performance issues; manages Supplier Corrective Action Requests.
Performs on-site and remote supplier quality audits for new suppliers; participates in supplier approval process.
Documents and follows up on audit results and required actions to be addressed by the supplier.
Tracks, analyzes, and reports supplier performance metrics to stakeholders within quality, logistics, and manufacturing management using the appropriate software tools.
Performs problem analysis, process, and machine capability studies as required; determines and proposes statistical process controls for appropriate supplier processes.
Developing professional expertise; applies company policies and procedures to resolve a variety of issues.
Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action.
Builds productive working relationships.
May provide assistance to lower level staff with general tasks that require a better understanding of functions, as directed by immediate supervisor.
May refer to senior level staff for assistance with higher level problems that may arise.
Escalates issues to supervisor/manager for resolution, as deemed necessary.
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
Assists with various projects as assigned by direct supervisor.
Responsible for Supplier Management.
Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bachelor’s Degree required in engineering or science.
EXPERIENCE AND REQUIRED SKILLS:
Minimum 2 – 5 years of related experience, preferably with pharmaceutical manufacturing; or an advanced scientific or engineering degree without experience; or equivalent directly related work experience.
Experience using quality tools.
Problem solving ability, strong analytical skills and diplomacy required.
Must possess good computer skills.
Strong oral and written communication skills.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Pharma Contract Manufacturing Organizations
Reviews completed production Batch Records from Contract Manufacturing Organizations for accuracy, completeness, and conformance to all applicable procedures. Makes lot release decisions in connection with established acceptance criteria.
Ensures proper maintenance of Master Batch records and material specifications.
Ensures quality specifications for incoming raw materials, in-process components, and finished products are established.
Reviews analytical data for raw materials, stability, conformational tests, USP validation/verification etc.
Reviews product and material non-conformances for all incoming, in-process and final product.
Reviews product complaint investigations
Participates in product design activities for new product lines or product transfers.
Reviews, and/or assists in the implementation of Validation Protocols, Final Validation Reports, Quality System Procedures, Performance Qualifications and Technical changes.
Reviews process improvement recommendations and participates in planning and implementing manufacturing changes with the Contract Manufacturer.
Reviews new documents and changes to existing documents to assure enhanced quality and productivity while maintaining compliance with Fresenius Corporate and FDA requirements.
Conducts risk analysis (Fault Tree, FMEA, FMECA, HACCP or equivalent accepted methods) within a scope of applicable Regulations, Fresenius procedures and contractual agreements.
Performs periodic audits of Contract Manufacturer’s quality systems and raw material suppliers to ensure that the pharmaceutical facility’s Quality Systems are established and maintained in compliance with applicable local ordinances, State statutes and Federal regulations, and other laws, including FDA’s 21 CFR 210 and 211.
Performs trend analysis of quality data associated with Fresenius products and provides feedback to the supplier following internal Fresenius procedures (ex. SNCR/SCAR process).
Maintains department working procedures, records, and other documents.
Participates in the suspect product identification process.
Leads and participates in continual improvement projects.
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
Fresenius Medical Care North America
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