QA / RA Manager

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.

QA/RA Manager

The QA/RA Manager is responsible for leading OPT Industries Quality and Regulatory efforts, working cross functionally to build and manage systems that ensure products and processes are both compliant with relevant standards and regulations, and exceed customer requirements and expectations.Build and scale a best-in-class QA/RA organization, that drives structure and rigor into quality efforts while maintaining an agile approach that supports the business in a unique manufacturing environment.

The location for this position is Medford, MA.

Principal Responsibilities

• Lead the organization in developing and deploying a Quality Management System meeting ISO 9001 standards.Champion 100% compliance to applicable regulations and internal SOPs.
• Provide guidance from a Quality and Regulatory perspective throughout new product development processes, manufacturing transfer, and product launch efforts.
• Hire, train, develop and manage quality inspectors, and regulatory support staff or consultants to ensure on-going high level of quality product delivered to customers.
• Lead quality investigations, CAPAs/internal audits, applying knowledge of currentregulations, requirements of ISO standards, and local procedures, to ensure compliance and high levels of quality are maintained.
• Work closely with the sustaining engineering team to drive down manufacturing and product variability using a data driven and risk-based approach.
• Identify and manage testing and regulatory related suppliers including notified bodies, product testing houses and sterilization services.
• Develop validation procedures and provide process validation guidance to support engineering initiatives.
• Manage the quality inspection team, responsible for incoming material, product design, and in-process material testing.Provide hands-on leadership, validating quality control and testing processes.
• Lead by example, demonstrating values of accountability, integrity, engineering excellence, collaboration, curiosity, a bias for action, and driving initiatives to completion.
• Review manufacturing, quality, engineering SOPs, FMEAs, process validations (MVP, CSV, IQ, OQ, PQ) through document control system for conformance to applicable regulations and business needs.
• Develop test methods, inspection plans, and sampling plans for manufacturing in-process inspections along with raw material incoming inspection specifications.
• Provides engineering guidance and execution of deliverables for incoming inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures.
• 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.
• Design and conduct experiments for process optimization, quality improvement, and cost reductions.
• Lead supplier quality management initiatives, monitoring supplier performance, risk, and leading the development of audit programs and quality investigation processes.

Qualifications

• 5+ years of quality engineering experience supporting manufacturing and quality management within a regulated industry.Bachelors degree in related field.Comfortable working hands developing processes and inspection methods.
• Detailed knowledge of GMP and ISO 9001.
• 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/Lean)
• Experience implementing and/or sustaining Quality Management System along with document control management.

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.