Process Quality Engineer (Medical Audio Devices)

  • Post Date: 2020-03-10
  • Apply Before: 2020-04-09
  • Job Level: Manager
  • Min Year of Experience: 5
  • Min Qualification: Bachelor Degree
  • Based In: Home-based
Job Description
Our customer-

Our client is a manufacturing company which predominantly sells audio equipment.

The company was established in 1964 and is based in Framingham, Massachusetts.

Our client is best known for its home audio systems and speakers, noise-cancelling headphones, professional audio products and automobile sound systems. Our client has a reputation for being particularly protective of its patents, trademarks, and brands.

Job Description: 

Drive manufacturing excellence and ensure compliance to company rules and applicable medical device regulatory requirements for all finished goods delivered to our customers. Working jointly with all manufacturing locations to drive continuous improvements in all facets of manufacturing operations, leading to best in class performance in Quality, Cost, Delivery and Service to our customers Including:

•Supporting new product launches

•Providing best in class experiences to our customers at the lowest total cost.

•Working seamlessly with our value chain partners to deliver maximum value to our customers.

•Quickly respond to product or process issues within our value chain partners, preventing any negative impact to our customers.

•Ensuring compliance with company rule and applicable regulatory medical device requirements.

Responsible for ensuring Contract Manufacturers continually and consistently meet or exceed company product quality standards. Establishes and monitors KPI’s related to CM Quality performance, and drives continuous improvement activities related to internal yield loss and field quality. Leverages cross functional teams within internal team and at the CM to ensure new and existing processes are capable with effective controls identified and strictly adhered to. Actively participates in Lean initiatives focused on improving quality and/or cost. Develops and prioritizes a process audit schedule to ensure that designated suppliers are audited on a regular basis to ensure supplier complies with all process and finished product requirements. Works closely with internal team and CM NPI teams to ensure processes are capable, controlled and stable prior to ramp. Regularly assesses the CM’s processes to ensure capability exceeds company’s specification requirements. Provides technical expertise and ensures the quality system is compliant with regulations including the FDA Quality System Requirements (QSR), ISO 13485, and other national and international requirements.

Duties & Responsibilities: 

•Ensure CM equipment qualification and process validation activities (IQ/OQ/PQ) meet company’s rules and applicable regulatory requirements. Approve qualification and validation protocols and reports.

•Review and approve Device History Record (DHR) for acceptance and release of each lot of Medical Device product.

•Establish and monitor KPI’s for CM performance related to Product Quality, 8D Time to Closure and Continuous Improvement Projects (CIP)

•Assess and report out CM Quality performance at Quarterly Business Reviews.

•Perform regular process and product audits at the supplier to ensure strict compliance to change management, control plan and final product requirements.

•Continuously assess risk though PFMEA reviews and work with CM to implement effective mitigation.

•Liaison between the CM Supplier and company’s support groups including Product Development, Process Development Engineering, Design Assurance Engineering, and Continuous Improvement Engineering.

•Lead cross functional team in resolving supplier quality issues by driving 8D problem solving analysis.

•Support cost reduction activities identified through VAULT and other initiatives.

•Qualify product and process updates associated with Continuing Improvement Engineering (CIE) projects.

•Drive Continuous Improvement Projects at the CM focused on quality and process improvement, efficiency gains, and waste elimination (Lean)

•Interface with Project Team for smooth transition from NPI to Production

•Ensure robust and compliant Change Management process at the CM to ensure CM initiated changes are properly controlled

•Project Manage qualification and approval of all Process Change Notifications (PCN’s)

•Interact and form constructive working relationships with all levels of leadership within the Contract Manufacturer’s Quality, Procurement, and Operations groups.

•Project Manage critical 8D’s and report out to Executive Team as required.

•Ensure best practices are identified, shared and implemented in each of their supported CM sites.  

•Support CIE qualification builds at CMs for new product variants and PCN activities.

•Oversea in-region based activities and meetings. (8D, CIE, Field Quality, SEE, etc.)

•Ensure regional team engagement in NPI process to allow for a smooth PQx hand off from development to production.

•Oversee the implementation of the corporate improvement strategies related to cost, quality and delivery across all of their supported CM sites.

•Leader of any Tier 1 Contract Manufacturer, customer or field quality issue requiring process corrective actions for all of their Health supported CM sites in conjunction with company’s Post Market Surveillance and Regulatory teams.

•Ensuring CM performance and capabilities are captured and communicated to corp. ME management for supplier selection strategies.

•Drive actions to improve performance regarding CM KPIs and maturity metrics.

•Provide QBR scoring for all Health related CM sites.

•Responsible for up keep and monitoring of KPIs by CM sites they support through weekly review meetings.

•Ensure utilization and compliance to ME core process tools and procedures at each of their supported CM sites.

•Ensure all Rapid response issues are addressed by each of their supported CM sites.

•Provide SME support for all regional ME teams as required.

•Provide CI/CR documentation to Corp. ME management for driving cost reduction negotiations with CMs.

•Perform regular process and product audits

•Capture Lessons Learned for all product and production issues at the CM sites they support.

•Identify gaps in CM capabilities and drive actions to address them.

Required Skills: 

•Knowledge of or experience in developing, manufacturing and validating medical devices in conformance with 21 CFR 820 , ISO 13485 and ISO 14971 requirements, etc.

•Experience with driving continuous improvement projects related to quality and cost with measureable results.

•Supplier Quality experience with Medical Devices, Consumer Electronics or products with comparable complexity.

•Manufacturing process expertise related to Final Product Assembly and critical sub-components.

•Knowledge of PPAP, Process Validation, Equipment Qualification (IQ, OQ, PQ), 8D Corrective Action, SPC, ISO 13485, 21 CFR 820, Six Sigma, Lean Manufacturing.

•Ability to proficiently perform Design for Manufacturability, Assembly and Test (DFx) Analysis.

•Skilled in driving a robust change management process with the Supply Base

•Excellent Project Management and communication skills are critical.

•Experience with performing Process Capability, Control Plan, and Product Audits at suppliers.

•Experience interfacing with all levels of Management internally and at the Supplier.

•Demonstrated ability to influence key decision-makers both within company and at the supplier.

•Experience with Microsoft Office Programs (Excel, Word, PowerPoint)

•Proficiency with reading Mechanical Drawings and working knowledge of GD&T.

•Knowledge of SAP and AutoCAD a plus.

Required Education/Experience:

•BS/BA degree in Manufacturing, Mechanical, Industrial Engineering or related discipline

•Minimum 5 years Quality Engineering experience in medical devices

•Minimum 5 years engineering experience in medical devices preferred.

•Ability to travel as needed.

•Good leadership skill with good communication skill.

•Strong ability to influence key decision-makers with good problem solving skills.

•Knowledge of SAP and AutoCAD a plus.

Good Spoken and written English (TOEIC 750+) and Asian language ability (Chinese or Thai) a plus