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Quality Engineer II (Senior Supplier Quality Engineer )

Company:
Lancesoft Inc.
Location:
Milpitas, California, United States
Posted:
April 20, 2019

Description:

Description:

The Senior Supplier Quality Engineer provides overall quality assurance leadership, serving as supplier-related QA technical and compliance lead for pre- and on- market product by ensuring the outsourced activity and associated product is qualified for use by the business unit. Key areas of focus within supplier management are leading supplier and process qualifications, leading issue/defect resolution, managing performance monitoring/reporting, compliance to company standards, and stream lining processes. Key areas of support provided to team members include; risk management/ communication, defect resolution, process capability/process improvement, and quality assurance general support. Adheres to environmental policy, procedures, and supports department environmental objectives.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES

Main areas of responsibility:

• Actively participate on cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations.

• Participate in local site supplier/EM quality meetings to ensure communication and alignment of quality initiatives/objectives. Support internal and/or external cross-functional and cross sector project teams driving supplier/EM improvement and general initiatives through reducing variations in supply chain, institute control plans, and improving process capability.

• Facilitate supplier quality system audits and associated actions.

• Provide internal and third-party inspection support. Accountable, as applicable, for compliance in accordance with regulations such as and from, but not limited to, FDA 21 CFR 820, ISO 13485, EU MD Directive/Regulations, Japan PAL, Canada CMDCAS, Brazilian ANVISA, and Australian TGA for assigned products.

• Support internal and lead supplier root cause investigations and corrective actions. Lead defect resolution, root cause investigation, and continuous improvement activities. Collaborate across functions to confirm if non-conformances are supplier/EM related as applicable.

• Monitor and report supplier and internal performance and quality metrics and support product/process improvements.

• Support product development by ensuring suitability of internally-developed specifications, instructions and test methods and leading the design transfer to the supplier, including providing QA technical and compliance expertise for risk analysis/assessments and process/test method validations.

Main areas of responsibility in addition to the items listed above:

• Participate in decisions that are aligned with management objectives regarding work processes, plans and schedules in order to achieve department objectives.

• Tracks and reports progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans.

• Monitors compliance with company policies, procedures and applicable regulatory requirements.

Qualifications:

Minimum education required for competent performance:

• A Bachelor's Degree in Engineering, Electrical, Mechanical or Industrial or related science/technical field or an equivalent is preferred.

• Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:

• 5 years experience in an FDA regulated industry (Biotech, Pharma or Medical Device manufacturing) is required

• Basic understanding of the Medical Device Quality Systems is required.

• Working knowledge of Word, Power Point and Excel with competency in moderately complex functions for data analysis and trending is required.

• Experience in the Medical Device industry is preferred. Experience in the Pharmaceutical industry or Electrical, Mechanical, Chemical, Packaging, Plastics or other manufacturing industry is preferred.

• Basic understanding of FDA and ISO regulations is preferred. Experience with 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; Canadian CMDCAS; Japanese PAL; Brazil ANVISA, Australian TGA, and EU MDR is preferred.

Additional Position Requirements – Up to 30% travel, Full Time with weekday business hours.