Manages the Quality Engineering team to support new product development, process quality, CAPA, post-market compliance, supplier management, project management, internal & external auditing, and risk management activities with respect to global regulatory requirements and MDSAP (FDA, ISO, EU MDR, ANVISA, MHLW, and TGA).
General Duties and Responsibilities:
Ensure the ongoing integrity, adequacy, and appropriateness of the Quality Management System and associated processes.
Provide technical support, leadership and quality guidance to multi-functional teams, including Quality, Regulatory, R&D, Operations, Engineering, and Marketing.
Select, develop, and evaluate Quality Engineering staff to support all aspects of design and manufacturing quality.
Act as assistant to the Management Representative during regulatory and customer audits.
Develop and implement and improve efficient quality systems processes.
Utilize project management strategy at a department level to successfully execute multiple projects with competing resources and prioritization.
Establish and maintain quality metrics and utilizes KPIs to drive improvements.
Manage the CAPA program (to include Complaints, SCARs, NCMRs, Audit Non-Conformances and Corrective & Preventive Action projects). Ensure thorough investigations and implement effective corrective actions to prevent recurring issues.
Utilize root cause analysis and statistical techniques for complex problem solving of technical product and manufacturing issues.
Ensure a high level of supplier quality through effective supplier evaluation, approval, and monitoring processes. Collaborate with internal supply chain and external suppliers to drive continual improvement of supplier quality.
Develop and maintain FMEAs, Controls Plans, and SOPs to identify and mitigate risks.
Support the development and validation of new products and production lines.
Write, review, and approve documents (SOPs, Protocols, Reports, and ECOs) pertaining to key quality system elements affecting product quality.
Apply basic risk management principles to all aspects of the quality system.
Qualifications:
Required:
Technical Engineering or Science degree at the Bachelor level or above.
8+ years of quality engineering experience in a highly regulated industry.
3+ years managing team members with varied backgrounds, experience, and technical capabilities.
Excellent working knowledge of medical device regulations and industry standards pertaining to manufacturing (FDA 21 CFR Part 820, ISO 13485, EU MDR (2017/745), the Medical Device Single Audit Program (MDSAP), and ISO 14971), IEC 60601.
Demonstrated project management skills, including the ability to prioritize and manage multiple project workloads in a highly dynamic production environment.
Solid working background utilizing quality management methods and tools (CAPA, Root Cause Analysis, FMEA, Control Plans, Statistical Techniques, MSA, etc.)
Demonstrated experience using trending and analysis reporting to drive organizational improvements.
Ability to develop and deliver clear communications (written and verbal), ensuring timely and relevant communication.
Some travel, domestic or international, may be required (up to 25%).
Preferred:
ASQ Certified Quality Manager or Certified Quality Engineer
ISO 13485 Lead Auditor
Lean Six Sigma Green Belt or Black Belt
Working knowledge of IEC 60601 and IEC 62366
Experience with sterile product assembly and packaging
Experience with electronics assembly
Quality Engineering Manager • Allen, TX, United States
Crown Technical Systems, a Flex Company, is a leader in power distribution and protection systems concentrating on sophisticated, state-of-the-art relay and control panels, medium voltage switchgea... Show more
Up to 25% travel to surrounding states.Relocation assistance available.The Engineering Project Manager is responsible for providing technical support, and oversight to all commercial, operational, ... Show more
The Quality Manager ensures all products meet customer requirements by leading the plant's Quality Management System (QMS), driving daily quality activities, customer service support, and making in... Show more
Signicast is the industry's leading investment casting manufacturer.Through the hard work and dedication of our employees, we satisfy our customer's needs by safely delivering a quality product on-... Show more
Engineering Manager IFor more than 100 years, Modine has solved the toughest thermal management challenges for mission-critical applications.Our purpose of Engineering a Cleaner, Healthier World me... Show more
AI data lab for training frontier models and evaluating AI agents.Experts contribute their diverse subject matter knowledge across domains such as finance, healthcare, STEM engineering, and more.AI... Show more
Our core competencies include systems engineering, program management, logistics, production support, aircraft maintenance, and aviation/aerospace services.We were founded in 2015 and since our est... Show more
Manages the Quality Engineering team to support new product development, process quality, CAPA, post-market compliance, supplier management, project management, internal & external auditing, and ri... Show more
Senior Manager, Software Engineering, Full Stack.Do you love building and pioneering in the technology space? Do you enjoy solving complex business problems in a fast-paced, collaborative, inclusiv... Show more
We are looking for an Engineering Manager (AI) to join our team.This individual will manage and provide technical support to technical engineering teams across multiple initiatives and develop new ... Show more
Zentech is one of the leading and most highly certified U.Electronics Manufacturing Services (EMS) providers in North America.We support original equipment manufacturers (OEMs) of medical devices, ... Show more
SitusAMC is where the best and most passionate people come to transform our client's businesses and their own careers.Whether you're a real estate veteran, a passionate technologist, or looking to ... Show more
Senior Air Quality Project Manager.WSP is currently initiating a search for a Senior Air Quality Project Manager to join our Houston, TX; San Antonio, TX; Dallas/Fort Worth, TX; Austin, TX; El Paso... Show more
FusionPKG Manager of Packaging Quality & Regulatory.The Manager of Packaging Quality & Regulatory will lead the Quality team at FusionPKG (the full-pack and turnkey division of Aptar Group in NA) t... Show more
Heads Up Technologies Group is seeking a Quality Manager to oversee quality operations for its Innovative Advantage business.This role is responsible for developing, maintaining, and continuously i... Show more
This role is based at one of our corporate offices in Memphis, TN or Dallas, TX Exceptional Hospitality Starts with YouThis is your chance to be a part of an in-house Technology team that's creatin... Show more
Dematic Corp has an immediate need for a Controls Engineering Manager to manage a team of project execution engineers within our Project Engineering Organization.The successful candidate will have ... Show more
Senior Customer Quality Manager.The Senior Customer Quality Manager is an important customer-facing, hands-on role within the Global Customer Quality Engineering (CQE) team responsible for customer... Show more
Crown Technical Systems, a Flex Company, is a leader in power distribution and protection systems concentrating on sophisticated, state-of-the-art relay and control panels, medium voltage switchgea... Show more
The Software Engineering Manager will lead the development and delivery of high-quality web applications to serve our business customers, ensuring alignment with corporate technology and innovation... Show more
