About OPT Industries
The global ecosystem of manufacturing is experiencing fundamental change. Additive manufacturing is a key technology to shorten supply chains and create superior products in medical, cosmetic, textile, and packaging industries, as well as and many other domains.
OPT Industries (http://optindustries.com) is a rapidly growing, venture-backed MIT spinoff company that focuses on building the next generation of additive manufacturing technology. We design and manufacture custom textile materials and products - everything from medical devices to luxury fashion. As we continue to grow and expand our operation, we are looking for manufacturing assistants to join our production team.
The Senior Quality Engineer is responsible for day-to-day manufacturing support, non-conformance, and acts as the independent review function. This role will support additional process such as Internal Audit, CAPA, and Post Market Surveillance. This role will fulfill the role of both contributor and independent reviewer for their assigned product lines. This position is responsible for Supplier Quality Management including qualification, issue resolution, change management, and performance monitoring of Suppliers within a highly regulated Medical Device manufacturing environment.
· Review and approve manufacturing SOPs, quality SOPs, manufacture engineering SOPs, FMEAs, process validations (MVP, CSV, IQ, OQ, PQ), and other applicable documents through document control system for conformance to FDA regulations along with business SOPs.
· Develop test methods, inspection plans, and sampling plans for manufacturing in-process inspections along with raw material incoming inspection specifications.
· Contributes to the development, maintenance and improvement of supplier development quality program policies, procedures and forms.
· Provides engineering guidance and execution of deliverables for incoming inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures.
· Manages development of supplied product inspection procedures and first article requirements.
· Applies sound engineering analysis and judgment to reduce the need for inspection at final, in-process, and incoming inspection to drive quality at the source.
· Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits.
· Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions.
· Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews.
· Contributes and participates in supplier performance reviews.
· Works with Manufacturing engineering to assess and address purchased product issues.
· Design and conduct experiments for process optimization, quality improvement, and cost reductions.
· Facilitate, participate in and/or lead formal risk assessments.
· Plans and leads audits of suppliers to assess compliance with regulatory requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
· Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using: quality policy, quality objectives, audit results, and analysis of data.
· Support the Risk Management Process per ISO 14971 and construction / maintenance of the Risk Management File.
· Identifies and advises leadership on potential improvements to quality systems and processes in the company.
· Champions 100% compliance to ISO regulations, company policies and SOP’s.
· Work closely with functional teams including Supply Chain, Manufacturing, Manufacturing Engineering, Advanced Manufacture Engineering, Facilities / EHS, and other functions to provide guidance and expertise on Interpretation of cGMP, regulatory requirements, directives, and guidelines from Quality Management System and from established regulatory agencies that OPT Industries is doing business within those regions.
· Review and perform Quality Assurance approval of complex change controls, responses, investigations, and CAPAs. Apply and interpret current regulations, requirements of ISO standards, and local procedures, to ensure records are clearly and appropriately justified.
· Support continuous improvement of quality and manufacturing systems using LEAN tools and implementation of actions arising from continuous improvement events.
· Provide statistical support and expertise along with analytical problem solving for manufacturing.
· Carry out duties in compliance with all state and federal regulations and guidelines, including FDA, EPA, and OSHA.
· Adhere to the Safety Code of Conduct & EHS policies and attend all required EHS training.
· Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
· 5+ years of quality engineering experience supporting manufacturing and/or supplier quality management within a regulated industry
· Bachelor’s Degree in Engineering, Sciences, or related discipline, Masters Degree preferred
· Engineering experience and demonstrated use of Quality tools/methodologies.
· Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
· Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
· Advanced computer skills, including statistical/data analysis, presentation, and report writing skills.
· Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean).
· ASQ CQE or other certifications preferred.
· Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
· Ability to travel approximately 5 - 10%, including internationally.
· Experience in change control.
· Experience in supplier quality management.
· Knowledge of regulatory agency enforcement trends
· Experience implementing and/or sustaining Quality Management System along with document control management.
OPT Industries provides the following benefits to all full-time employees:
Medical, Dental, Vision, 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.