Sr. Manager Quality Engineer

Imperative Care•Campbell, CA

2d•$190,000 - $210,000

About The Position

Manage Supplier Quality Engineering group and Contract Manufacturing Quality in support of the manufacturing, development, and distribution of Imperative Care’s medical device products consistent with the Company’s Quality Policy and Quality Objectives. Establish and maintain quality assurance standards that adhere to ISO 13485, FDA, and other governmental regulations within Supplier Management processes and group. Manage and direct the collaboration with suppliers/CMs/OEMs and business partners to ensure robust materials, products, processes, and systems. Manage all employee related activities, including day-to-day resourcing, hiring, mentoring and on-going development of the staff. Recommends changes to policies and establishes procedures that affect section or multiple disciplines. Partner with Procurement, R&D, Operations, Supply Chain and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions. Monitor the analysis of supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes. Monitor and manage SCARs resolution and implementation of each SCAR, managing the SCAR age metric. Managing supplier Audits/requalification process. Managing the Incoming Inspection Team, process, oversee incoming inspection acceptance activities, offering direction to specify and develop component acceptance criteria/test procedures for purchased subassemblies and components. Spearhead and supplier related non-conformances, including leading/participating in investigations. Analyse product/components failures, metrics and deep failure analysis to offer advice in project management activities that address said failures and metrics improvement. Develop, implement and monitor various quality metrics. Identify opportunities for continuous improvement and customer satisfaction. Compile and represent data for quality process reviews identifying issues/performance, or component design improvement activities. Help in project management activities for a series of product, compliance and quality projects Ensure compliance to regulatory requirements. Uphold quality system. Support internal and external audits. Provide quality metric data to various functional groups within the organization. Actively promote and support the company’s management review process. Conduct Supplier qualification audits for new supplier (when is required) by planning, conducting, reporting, and follow-up on supplier quality system audits. Drive and execute supplier quality agreements by working with different department within ICI and the suppliers. Oversee the component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups. Apply Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for supplier quality management (SQM) projects. Responsible for presenting supplier-related issues or opportunities to next management level. Manage all departmental employee related activities, including the day-to-day resourcing, hiring, mentoring, and on-going development to the staff. Manage, Train and mentor engineers, IQC Technicians and other project team members on best practices in quality engineering and regulatory compliance to external standards.

Requirements

BS in Engineering or related discipline and 8+ years of supplier quality experience; or MS in Engineering with 6+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
Lead development and validation of test methods to comply with recognized standards
2+ years of supervisory experience strongly preferred
Experience leading supplier or process issues (CAPAs, NCRs, SCARs, etc.)
Must have strong knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485), risk management standards (ISO 14971), and good manufacturing practices.
Excellent communications skills (both written and verbal)
Must be able to write clear, concise, and well thought out technical documentation.
Ability to communicate effectively, both orally and in writing, with all organizational levels
Strong attention to detail and ability to function in a fast-paced dynamic environment.

Nice To Haves

Lead auditor certification a plus

Responsibilities

Manage Supplier Quality Engineering group and Contract Manufacturing Quality
Establish and maintain quality assurance standards that adhere to ISO 13485, FDA, and other governmental regulations within Supplier Management processes and group.
Manage and direct the collaboration with suppliers/CMs/OEMs and business partners to ensure robust materials, products, processes, and systems.
Manage all employee related activities, including day-to-day resourcing, hiring, mentoring and on-going development of the staff.
Partner with Procurement, R&D, Operations, Supply Chain and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions.
Monitor the analysis of supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.
Monitor and manage SCARs resolution and implementation of each SCAR, managing the SCAR age metric.
Managing supplier Audits/requalification process.
Managing the Incoming Inspection Team, process, oversee incoming inspection acceptance activities, offering direction to specify and develop component acceptance criteria/test procedures for purchased subassemblies and components.
Spearhead and supplier related non-conformances, including leading/participating in investigations.
Analyse product/components failures, metrics and deep failure analysis to offer advice in project management activities that address said failures and metrics improvement.
Develop, implement and monitor various quality metrics. Identify opportunities for continuous improvement and customer satisfaction.
Compile and represent data for quality process reviews identifying issues/performance, or component design improvement activities.
Help in project management activities for a series of product, compliance and quality projects
Ensure compliance to regulatory requirements. Uphold quality system. Support internal and external audits.
Provide quality metric data to various functional groups within the organization.
Actively promote and support the company’s management review process.
Conduct Supplier qualification audits for new supplier (when is required) by planning, conducting, reporting, and follow-up on supplier quality system audits.
Drive and execute supplier quality agreements by working with different department within ICI and the suppliers.
Oversee the component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups.
Apply Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for supplier quality management (SQM) projects.
Responsible for presenting supplier-related issues or opportunities to next management level.
Manage all departmental employee related activities, including the day-to-day resourcing, hiring, mentoring, and on-going development to the staff.
Manage, Train and mentor engineers, IQC Technicians and other project team members on best practices in quality engineering and regulatory compliance to external standards.