- 30% QA Manufacturing
- 20% Design quality
- 20% Transfer to Manufacturing/Validation Support
- 20% QMS Development/Management (eQMS)
- Provide technical support and guidance from a Quality perspective throughout the new product development and transfer to manufacturing process.
- Develop quality control plans, monitor and analyze quality performance, investigate production issues.Use data and statistical analysis to support effective quality assurance and drive manufacturing improvements.
- Provide technical quality leadership to project teams for project decisions and deliverables (Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation).
- Creation and review of Risk Management documentation such as Design Failure Mode and Effects Analysis (DFMEA).
- Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. 5 Whys analysis, DMAIC problem solving methodologies).
- Lead the organization in deploying a Quality Management System that complies with ISO 9001.Support documentation and compliance cross functionally, owning our eQMS system.
- Write/review manufacturing, quality, engineering SOPs, FMEAs, and validations (MVP, CSV, IQ, OQ, PQ) to ensure conformance with regulations, as well as customer and business needs.
- Develop test methods, inspection, and sampling plans for manufacturing in-process inspections along with raw material incoming inspection specifications.Apply sound engineering analysis and judgment to reduce the need for inspection at final, in-process, and incoming inspection to drive quality at the source.
- 5+ years of technical engineering experience in manufacturing and quality management.
- 5+ years of hands-on experience with the validation/qualification of new products, equipment, and processes.
- Bachelors degree in an engineering discipline.
- Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues.
- Experience leading process improvement projects using Six Sigma or Lean methodologies.
- Experience implementing and/or sustaining a Quality Management System
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Lead Quality Engineer - Boston, United States - OPT Industries
Description
Company Description:
OPT Industries ) is a rapidly growing, venture-backed MIT spinoff company that focuses on building the next generation of additive manufacturing technology. Working at the intersection of automation engineering, computational design, and polymer science, we design and commercially manufacture highly customizable materials and products- everything from medical devices to luxury fashion.
Lead Quality EngineerRole:
Multifaceted, hands-on technical Quality Engineering role responsible for leading OPT Industries Quality efforts with regards to design quality, manufacturing quality insurance, and quality system (QMS) development and management.
Principal Responsibilities:
Qualifications:
Benefits:
OPT Industries provides the following benefits to all full-time employees: Medical, Dental, STD, LTD, Life and AD&D Insurance, Tax Free Commuter Benefits, 401k, and more.
OPT Industries is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
