Sr Quality Engineer - Exempt

LanceSoft Inc

Danvers, MA

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

American Society for Quality (ASQ), Analysis Skills, Cardiovascular, Certified Quality Engineer (CQE), Code of Federal Regulations, Cost Analysis, Design Failure Mode and Effects Analysis (DFMEA), Digital Rights Management (DRM), Experiment Design, Failure Mode and Effects Analysis (FMEA), ISO (International Organization for Standardization), Industry Standards, Interpersonal Skills, Inventory Management, Manufacturing, Medical Equipment, Medical Office Administration, Medical Products, Peripheral Hardware, Presentation/Verbal Skills, Procedure Implementation, Process Failure Mode and Effects Analysis (PFMEA), Process Quality, Process Validation, Product Support, Product Testing, Production Control, Quality Assurance, Quality Assurance Methodology, Quality Engineering, Quality Management, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Requirements, Research & Development (R&D), Risk Analysis, Risk Management, Root Cause Analysis, SAP, Six Sigma Green Belt, Six Sigma Master Black Belt, Statistics, System Validation, Technical Presentation, Technical Writing, Testing, United States Department of Energy (DOE), Validation Testing

LOCATION

Danvers, MA

POSTED

30+ days ago

In this exciting role as a Senior Quality Engineer, you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives. This is an onsite role at the Danvers, MA location. Responsibilities Include: Provide Quality Engineering support for commercial medical device products. Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality. Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing. Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements. Present technical data to groups within and outside the organization. Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root cause analysis, reading and correcting drawings. Must Have: Minimum Qualifications Bachelor’s Degree in Engineering, Science or technical field AND 4 years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality. Nice to Have: Preferred Qualifications Medical Device Master’s degree Manufacturing Experience Green Belt Six Sigma/DRM Training/Certification ASQ-CQE, CQA, CBA or equivalent certifications SAP QM or SPC Software Experience Effective verbal and written communication, analytical, influencing and interpersonal skills Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016 Demonstrated working knowledge of process validation, statistical methods, risk management Top 3 Technical Skills Required for the Role: Medical Device Design & Development Risk Management: dFMEA, pFMEA, Statistical analysis Technical Writing: IQs, PQs, TMVs Additional Information Education Required: Bachelor’s Degree in Engineering, Science or technical field AND 4 years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality Years’ Experience Required: 4 years Work Schedule: 40 hours per week Work Location: 4 Days Onsite, 1 day remote (subject to change depending on project requirements) Interview Timeline: As soon as possible Product Line Supported: Cardiovascular, Neurovascular, Peripheral Devices

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

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