Overview:
This QE applies advanced Quality Engineering and scientific method techniques and principles to daily tasks and activities; applies relevant regulations, standards, and industry best practices to assignments; plans and conducts projects and assignments/activities with high technical responsibility, complexity or strategic input; Acts as a subject matter expert in routine Quality Engineering and scientific matters; receives occasional, summarized instructions from technical Quality leaders at various levels in addition to other functional stakeholders.
Responsibilities:
- Demonstrates high level of proficiency in applying various tools and methods to identify and realize new products or process introductions (ex. QMS, product related), and business improvements.
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Leads and contributes to the application of, and/or develops innovative applications for various risk management and risk mitigation tools and practices.
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Leads and/or contributes to root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions.
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Leads, conducts and supports the development of test methods in equipment, process, and product qualifications/validations.
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Develops, implements, and/or maintains process Quality control plans are in accordance with product utilization and risk level and are followed.
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Develops, reviews, implements and/or maintains process controls using appropriate techniques and tools (ex. Statistical process controls, statistical inspection sampling).
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Support and ensure all levels of Design Controls per ISO 13485:2016 and QMSR 21 CFR 820 are being utilized, in addition to other product regulatory requirements.
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Leads or participates in design/technical reviews as appropriate.
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Interprets and implements standard and non-standard sampling plans.
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Act as a subject matter expert (SME) in at least 2 routine Quality areas.
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Partners with senior technical leaders (internal and external to the organization) to develop innovative approaches for identifying technical opportunities and quality improvements.
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Mentors others in various technical capabilities.
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Liaising with customer quality personnel to resolve issues and Customer Complaints.
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Generating process deviations, Customer Change Notices, validation protocols & reports.
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Assisting with troubleshooting of processes.
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Assisting with production and product development processes.
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Leading development of metrology equipment.
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Developing and maintaining quality/control plans.
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Ensuring Quality Management Systems procedures and appropriate regulations and industry standards are being utilized throughout the product development and process development processes.
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Developing Risk documentation in compliance with the QMS and regulatory standards, such as PFMECAs.
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Conducting Gage R&R studies
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Resolving Corrective and Preventive Actions
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Developing Quality Procedures and conducting training to all personnel as appropriate
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Approving Nonconformance disposition
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Analyzing production and validation data
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Working on continual improvement and process assessment projects as assigned
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Author protocols or provides support in performing qualification validation protocols in support of design control deliverables.
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As a Quality Engineer on development projects, directly contribute and/or provide guidance to others to establish appropriate Design History File / Device Master Record documentation and provide detailed planning for product builds.
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Support Equipment Calibration and Maintenance requirements per the applicable procedures.
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To maximize the effectiveness of the position, this job description is subject to change according to a consensus of the 2 parties (Agile MV Technologies Inc «A Resonetics Company» and the employee).
Required Qualifications:
- Ability to create job-related documentation for quality purposes.
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Familiarity with ISO 13485 standards and 21 CFR 820 regulations.
- Minimum 2 years’ experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experience.
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Demonstrated technical writing and communication skills.
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Working knowledge of Statistical software and/or Minitab.
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Bachelor’s degree or equivalent experience.
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Interact with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information. Auditing and qualifications of new suppliers may be required.
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Advanced level of oral and written French.
Advanced level of English, to interact with customers and suppliers who are mainly international. To comply with international industry standards.
Preferred Qualifications:
- CQE and/or Six Sigma Green or Black belt.
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BS degree: Physics, Optics, Mechanical, Chemical, Plastics, Engineering
Preferred.
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Strong attention to detail and satisfactory organizational skills.
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Able to self-manage project tasks.
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Position may include up to 10% domestic and
international travel.
Compensation:
- Standing and walking for short periods of time.
- Ability to use a microscope, including manipulating small objects under a
Microscope.
