Senior Quality Engineer
Sorry, this particular job is closed. But feel free to fill out a General ApplicationSearch Jobs
Senior Quality Engineer
Title:Senior Quality Engineer
Senior Quality Engineer:
The Senior Supplier Quality Engineer is responsible for providing support with a focus on supplier quality management activities. Works with external manufacturers and suppliers providing finished products, services, components, and sub-assemblies to ensure compliance with company policies, procedures, and medical device regulations.
- Lead supplier quality management for legacy products and support of new products under development process.
- Lead component inspection plans, first article inspection reports (FAIR’s), and issue resolution (collaborate with Design Assurance or Quality Engineering, if design or process impacted).
- Lead corrective & preventive actions (CAPA’s), supplier corrective action requests (SCAR’s), and supplier notifications only (SNO’s) to resolution, including monitoring, analyzing, and reporting on supplier performance data and metrics.
- Lead the evaluation of new or transferred suppliers and/or changes to the Approved Supplier List (ASL).
- Lead post-launch supplier sourcing sustainment.
- Notify and present high impact to business SCN’s to Local Review Boards via Product Release Process (PRP).
- Support supplier process management, i.e., risk management, quality assurance agreements, control plans, supplier assessments / audits (QS status), submitted validations (IQ, OQ, PQ, PPQ), process failure modes and effects analysis (pFMEA), and supplier inspection plan / method evaluations.
- Utilize effective and efficient Quality Engineering techniques such as risk analysis, statistical data analysis, process capability analysis, design of experiments, measurement system analysis, control plans, and development of sampling plans throughout the product lifecycle.
- Author, collaborates and approve quality system documentation via Agile PLM.
- Perform other duties as assigned by management.
- Bachelor’s Degree in Engineering required. Master’s Degree preferred. Experience can be substituted for education requirements.
- Minimum 5 years of experience in process quality engineering in Medical Device Industry.
- Prefer experience with an emphasis on Supplier Quality Management within an FDA-regulated medical device manufacturing environment.
- Proficient with DMAIC / Black Belt / Six Sigma type tools to analyze, drive root cause, and solve problems.
- Proficient with statistics, sampling strategies, design of experiments, process capability, including statistical software tools such as Minitab.
- Strong written and oral communication skills are required.
- Proficient with process trouble shooting of parts utilizing injection and insert molding, extrusion, stamping, wire EDM, and CNC machining.
- Understanding of the design, development, and tolerancing of complex systems.
- Knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, & ISO 14971 are required.
- Ability to lead, champion change, and execute strategies to meet goals.
- Must be self-motivated with a strong sense of urgency and ability to deliver on required activities.
- Must have a sense of ownership and a desire to follow a project from inception to full production.
- Proficient in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio), including Agile PLM.
- ISO 13485 Lead Auditor certification is preferred.
- ASQ Certification (CQE & CBA) is preferred
- Quality Control Inspector in Brooklyn Park MN
- Warehouse Lead 3rd Shift in Worcester MA
- Entry-Level Maintenance Mechanic 2nd shift in Worcester MA
- Desktop Support in Suwanee GA
- Assembly Technician in Tucker GA
- Inspector in Central Manchester CT
- Inventory and Material Control Associate in Duluth GA
- Wire Processing Machine Operator in Brooklyn Park MN
- Technician in Cambridge MA
- Final Assembly in Norcross GA
- Quality Tech in Norcross GA
- Quality Inspector in Manchester NH
- Configuration Analyst in Framingham MA
- Maintenance Planner in Gainesville GA
- Lab Support Personnel in Memphis TN
- Principal Process Design & Development Engineer in North Canton OH
- MFG - process Engineer Automation Test Tech QA Engineer Material Planner in Manchester NH
- FPGA Designer - Firmware Development Engineer in Alhambra CA
- Lab and Tire Test Technician in Suwanee GA
- Electro - Mechanical Assembler in Maple Grove MN
- Precision Optical & Mechanical Inspector in Merrimack NH
- Technical Recruiter in Marlborough MA
- Sr. Software Engineer in Norwood MA
- Crimpers in Alpharetta GA
- Process Engineer in Covington GA
- Quality Inspection Technician in Wilmington MA
- Quality Engineer in Laconia NH
- AP- AR Specialist in Boylston MA
- Control Panel Power Wirer in Brooklyn Park MN
- Electrical Tester in Brooklyn Park MN
- Project Manager in Marlborough MA
- Talent Acquisition Manager in Marlborough MA
- Lean-FEM Coordinator in Doraville GA
- Instrument Assembler II in Eden Prairie MN
- Quality Engineer in Gainesville GA
- CAD Drafter in Ball Ground GA
- Supplier Quality Engineer in Gainesville GA
- Quality Technician in Gainesville GA
- CNC Lathe Machinist in Boylston MA
- Assembly Test Tech in Marlborough MA
- RMA Technician in Lawrenceville GA
- Stockroom Attendant in Gainesville GA
- Inventory Control in Duluth GA
- Product Design Engineer in Milford NH
- Process Engineer- Metallurgist in Milford NH
- Quality Inspector in Memphis TN
- Supplier Quality Engineer in Chaska MN
- Warehouse - 2nd Shift in Suwanee GA
- Modular Assembly - 2nd Shift in Suwanee GA
- Fabrication - 2nd Shift in Suwanee GA
- Manufacturing Tech (Entry Level- Skilled) in Ayer MA
- Office Manager in Huntsville AL
- Soldering in Suwanee GA
- Assembler in Norcross GA
- Digital Product Manager in Suwanee GA
- Customer Service Representative in Leominister MA
- Electrical Engineer in Lowell MA
- Mechanical Design Engineer in Woodbury MN
- QC Inspector in Manchester NH
- Welder in Alpharetta GA
- Maintenance Technician in Lithonia GA
- Lead Machine Operator - 2nd Shift in Suwanee GA
- Office Manager in Lexington MA
- Quality Assurance Technician in Hoschton GA
- Assembler II in Milford MA
- Microdeburer in Milford MA
- Machine Operator in Hoschton GA
- Manufacturing Engineer in Lowell MA
- Maintenance Technician in Hoschton GA
- Accounting-Administrative Support in Duluth GA
- Buyer in Brooklyn Park MN
- Assembler in Golden Valley MN
- Technical Recruiter in Suwanee GA
- Quality Coordinator in Mansfield MA
- Tooling Engineer in Newnan GA
- Manufacturing Engineer in Burnsville MN
- E&I - Maintenance Technician in Lithonia GA
- Wiring Technician in Hoschton GA
- Machine Operator in Plymouth MA
- Technical Recruiter in Marlborough MA
- Maintenance Tech in Lawrenceville GA
- Process Operator in Franklin MA
- Engineering Intern in Memphis TN
- Material Handler in Franklin MA
- Wire Harness Assembler in Brooklyn Park MN
- Manufacturing Technician in Burlington MA
- Production Control Associate in Cumming GA
- Quality Engineer in Duluth GA
- Structural Engineer in Ball Ground GA
- Manufacturing Engineer in Laconia NH
- Manufacturing Engineer in Tucker GA
- Senior Document Control Specialist in Cambridge MA
- Lead Mechanical Engineer in Fort Worth TX
- Industrial Seamstress in Suwanee GA
- Sr Test Engineer in Bedford MA
- Operator- Assembly Tech in Central Manchester CT
- Warehouse Shipping & Receiving Lead in Olive Branch MS
- Mechanical Assembler - 1st Shift in Ashland MA
- Manufacturing Engineer-Contract in Charlton MA
- Technical Recruiter-Program Manager - MN in Minneapolis MN