Planning: Develop and direct QC and QA oversight activities of incoming inspections to meet compliance/business requirements and anticipate future needs.
Plan and manage work load and business demand/project timelines to prioritize and direct resources for completion of supplier engineering projects and component releases.
Effectively plan and collaborate with internal and external customers to achieve management of quality systems for component releases and quality engineering systems for equipment and test methodology.
Assess new technology /regulatory guidance to plan for system and equipment enhancements and continual compliance.
Plan and schedule supplier assessments to support the global audit plan.
Technical: Develop and direct quality systems relating to incoming inspection programs to assure components, global chemicals, and supply items meet Alcon standards and standards dictated by health agencies. (FDA, CE, ICH, MCA).
Direct and approve non-conformance investigations and CAPA completions for lab non-conformances.
Support supplier review assessments to assure compliance with supplier requirements including verifications for TSE/BSE, audits, certifications, supplier agreements, and review of quality of receipts.
Direct and approve change control documentation for supplier notifications/process changes.
Direct and approve supplier change control documentation and equipment qualification documents.
Evaluate and present monthly supplier quality metrics for management oversight review.
Support supplier quality agreements to assure current and future requirements are established.
Provide quality engineering technical expertise and guidance for component investigations, technical reports for support of customer complaints, tooling/specification approvals, equipment validations, measurement system analysis, and all other activities of the incoming inspection program.
Direct and provide QA oversight for incoming inspection activities including component disposition.
Direct, develop, and establish standards and test methodology for incoming quality inspection plans including key process attributes and variable parameters.
Establish effective supplier quality engineering procedures and methodology to lead management of inspection test methodology and equipment qualification programs for FW and ASPEX facilities.
Review and approve SOPs/forms related to supplier quality engineering systems and incoming inspection program.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum; BS in Engineering or Sciences with at least 5 years' experience with pharmaceutical / medical device requirements
Must be fluent in English
Preferred Qualifications: Minimum of 2 years experience successfully supervising technical staff with application in Quality Systems; Working knowledge of US and International regulations governing the medical device / Pharma industry (i.e. cGMP, GLPs, ISO 13485, CFR 210/210, 820)
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