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Sr Quality Engineer - Exempt

LanceSoft Inc

Jacksonville, FL

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Analysis Skills, Coaching, Communication Skills, Cross-Functional, Documentation, English Language, ISO (International Organization for Standardization), Interpret Regulations, Leadership, Lean Six Sigma, Maintain Compliance, Manufacturing, Medical Equipment, Multilingual, Multitasking, Organizational Development/Management, People Management, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Process Validation, Product Flow, Product Lifecycle Management, Product Testing, Production Control, Project/Program Management, Quality Assurance Methodology, Quality Engineering, Quality Management, Quality Metrics, RPM, Regulatory Compliance, Reporting Skills, Research & Development (R&D), Risk, Risk Analysis, Risk Management, Root Cause Analysis, Six Sigma Certification, Six Sigma DMAIC, Spanish Language, Statistical Process Control, Statistical Sampling, Support Documentation, Talent Management, Time Management, Training/Teaching, Writing Skills
LOCATION
Jacksonville, FL
POSTED
30+ days ago
We are seeking a highly skilled candidate for an immediate opening to backfill an employee during a mandatory time-off period. This is a short-term position lasting 3 months, with responsibilities across multiple projects impacting various product lines. Must Have Bachelor's degree in Engineering, Science, or a technical field with a minimum of 4 years of experience in Engineering and/or Quality, or an advanced degree with 2 years of relevant experience. Experience in Validation/Qualification activities: writing, coordinating, executing, creating reports, IQ, OQ, PQ, MVPR, etc. Experience in Risk Documentation: writing, reviewing, approving Risk Management files, RPM calculations, Risk Mitigations, etc. Strong statistical background and sampling size determination for attribute or variable data. Ability to work with minimal supervision in a hybrid working setup. Excellent writing, documentation, organizational, and verbal communication skills. Ability to work in a fast-paced environment and meet deadlines. Ability to interact with a diverse team while maintaining high ethical standards. Commitment to the company's core values. Strong Risk Management Experience. Nice to Have ASQ Quality Engineer Certification. Bilingual in English/Spanish preferred but not required. Previous experience in the medical device industry. DMAIC Lean / Six Sigma Certification. Manufacturing experience within a controlled and regulated industry. Responsibilities Provide Quality Engineering support to multiple projects, including supplier quality engineering support. Conduct day-to-day Risk Management reviews and maintain strong Risk Management practices. Develop, execute, analyze, and report on validation/qualification activities such as IQ, OQ, PQ, MVP, and Test Method Validations. Evaluate, review, and update quality records, including design files and process documents, ensuring compliance with ISO standards and local procedures. Oversee the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal and external standards. Provide expertise and guidance in interpreting policies and regulations to assure compliance. Work with various internal and external entities to provide quality engineering and supplier quality engineering support. Prepare reports and necessary documentation for project stakeholders. Develop and apply quality standards and protocols for material processing. Implement inspection, testing, and evaluation methods for product precision and accuracy. Ensure corrective measures meet reliability standards and documentation requirements. Support multiple projects in areas such as design, production control, and research and development. Perform Root Cause Investigation using quality tools when required. Collaborate with cross-functional teams to resolve process issues and implement changes. Apply process control tools and statistical sampling techniques to enhance product quality and flow. Identify, analyze, and manage risk throughout the product life cycle using risk management tools. Differentiating Factors Autonomy: Operates independently under limited supervision, coaching lower-level specialists and potentially managing projects. Organizational Impact: Responsible for projects or processes, contributing to work group objectives through collaboration and consensus building. Innovation and Complexity: Solves complex problems, improves processes, and provides in-depth analysis with recommendations. Communication and Influence: Communicates with senior internal and external stakeholders, exchanging information to achieve objectives and influence decisions. Leadership and Talent Management: Provides guidance and training to other employees, manages projects, and delegates work as needed. Required Knowledge and Experience: Requires advanced knowledge of the job area, typically obtained through an advanced education combined with experience. Practical knowledge of project management is beneficial. Requires a University Degree and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.

About the Company

L

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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