Senior Supplier Quality Engineer
Company: Sunrise Systems, Inc.
Posted on: December 9, 2018
Sunrise System Inc. is currently looking for Senior Supplier Quality Engineer in Brooklyn Park, MN with one of our top client.Job Title: Senior Supplier Quality EngineerJob Id: 18-18018Location: Brooklyn Park, MN 55445Duration: 10 monthsPosition Type: Hourly contract Position (W2 only)Summary
- 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.
- The Senior Supplier Quality Engineer will partner with Manufacturing Engineering, Operations, R&D, Supply Chain and other departments to continuously improve products and processes that meet customer and patient requirements.Primary Duties and Responsibilities
- Lead supplier quality management for legacy products and support of new products under development per OSTA new product development (NPD) 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, analysing, 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.
- Lead Supplier Change Notifications (SCNs).
- 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.
- Collaborate and approve supplier sourced component and subassembly specifications and/or drawings.
- Uutilize 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.Supervisor Responsibilities (If Any) - Optional section
- At times, may lead, provide feedback on performance, and train other employees, including exempts and contractors. Set priorities as directed by Management and is expected to mentor less experienced team members.
- Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws, including training.Minimum Qualifications
- To perform this position successfully, an individual must be able to perform each essential duty satisfactorily.
- The requirements listed below are representative of the, education, knowledge, skill and/or ability required.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- 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 analyse, 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 tolerance 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.ContactAbdul. ADirect: - Email: OrMichael PengDirect: - - provided by Dice process quality, Medical Device, DMAIC, Black Belt, Six Sigma, statistics, Minitab, trouble shooting, ASQ, CQE, CBA, Lead Auditor
Keywords: Sunrise Systems, Inc., Minneapolis , Senior Supplier Quality Engineer, Engineering , Minneapolis, Minnesota
Didn't find what you're looking for? Search again!