- Performs and supports the work using quality risk management principles and their application to medical device manufacturing.
- Liaising with customer quality personnel to resolve issues and Customer Complaints
- Monitoring and disseminating customer quality report cards
- Generating process deviations, validation protocols and reports
- Generating Customer Change Notices
- Assisting with troubleshooting of production and process development processes
- Leading development of metrology equipment
- Developing and maintaining quality/control plans
- Developing PFMECAs
- Specifying metrology equipment
- Conducting Gage R&R studies
- Resolving Corrective and Preventive Actions
- Developing Quality Procedures and ensure training of personnel
- Approving Nonconformance disposition
- Analyzing production and validation data
- Working on continual improvement and process assessment projects as assigned
- Supervising quality department for a site
- Minimum 8 years experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experience
- Demonstrated technical writing and communication skills.
- Have proven experience leading the facilitation of external audits
- Working knowledge of 21 CFR Part 820 and/or ISO 13485 compliance
- Working knowledge of Statistical software and/or Minitab
- Bachelors degree or equivalent experience
- Prior supervisory experience
-
Quality Manager
3 weeks ago
Centrotherm Eco Systems, LLC. Waterford, United States: · The Quality Manager is accountable for spearheading and supervising the quality initiatives at Centrotherm. In this pivotal role, you will oversee the establishment and maintenance of efficient protocols while ensuring adherence to quality standards. This position entails col ...
-
Product Line Quality Manager
1 day ago
BAE Systems Sterling Heights, United States Full timeJob Description · How does it feel to work on a team driven to make a big impact? Empowering. · Are you a results-driven quality professional with a passion for excellence in defense technology? BAE Systems - Combat Mission Systems is seeking highly qualified Quality Managers fo ...
-
Quality Risk Management Specialist
3 weeks ago
CinTel Corp Sterling Heights, United StatesPosition Title: Quality Risk Management Specialist · Location: Sterling Heights, MI · Position Type: Full-Time · Cintel is a leading defense contractor dedicated to providing innovative solutions for the defense industry. We are currently seeking a Quality Risk Management Spec ...
-
Quality Manager
2 weeks ago
MMI Engineered Solutions Warren, United StatesJob Description · Job DescriptionSummary of Position: · Are you a seasoned Quality Manager looking for a dynamic opportunity in the automotive industry? MMI is seeking a dedicated individual to join our team as a Quality Manager at our Warren location. The Quality Manager will co ...
-
Quality Manager
3 weeks ago
Flex-N-Gate Troy, United StatesScope of the Position · The Quality Manager manages the quality department, implements and maintains the quality management and document control systems. They will interview, train, develop, evaluate, promote, and discipline subordinate personnel. Drive continuous improvement act ...
-
Quality Manager
2 weeks ago
Flex-N-Gate Corporation Troy, United StatesJob Description · Job DescriptionResponsibilities · Job DutiesEvaluate and develop improved techniques for control of quality and reliability. · Work with Process Engineering on process and engineering changes. · Support prototype builds and data collection and reporting of build ...
-
Supplier Quality Assurance Regional Manager
3 weeks ago
General Dynamics Sterling Heights, United StatesResponsibilities for this Position Job description Job Description IDENTIFY DETAILED DESCRIPTION OF WORK: Manage Supplier Quality Field Service Personnel to schedule, assign and direct actions:Activities related to part approval, AS9102.Assure product conforms to contractual requ ...
-
Quality Assurance Manager
3 weeks ago
CES Consulting LLC Sterling, United StatesJob Description · Job Description · CES Consulting, LLC is an engineering and construction management firm focused on quality, safety, compliance, innovation, and value. The firm was founded in 2010 by three professionals passionate about resolving complex construction, time, a ...
-
Quality Management Employee
3 weeks ago
Sapphire Enterprises Warren, United StatesQUALITY MANAGEMENT EMPLOYEE (M/F/D) · LOCATION: POTSDAM / BERLIN WHAT WE OFFER: · Diverse and exciting international work environment · Flexible working hours with various models (full-time, part-time, flextime, home office) for better work-life balance · Green workplace with ...
-
Quality Manager
1 week ago
ARNOLD Fastening Systems Rochester Hills, United StatesThe Quality Manager position is responsible for the overall development, implementation, and maintenance of the organization's Quality Management System (QMS). The Quality Manager must fully understand the requirements for the products and/or services and have a sense of responsi ...
-
Quality Manager
1 week ago
American Axle & Manufacturing Fraser, United StatesLeads the daily operations of quality and lean activities, including quality system and audits, continuous improvement programs, operational safety, and regulations requirements coordination. Handles staff and associated resources for quality-assuran Manager, Quality, Operations, ...
-
Quality Manager
2 weeks ago
Sentech Services Rochester, United StatesQuality Manager (Plant, not Corporate) Oakland County, MI Company is an automotive manufacturing facility Salary: $110k - $130k/ yr (+ up to 10% annual bonus) · Job Summary: · The Plant Quality Manager provides clear leadership for the development of an environment focused on ...
-
Construction Quality Assurance Manager
3 weeks ago
DAB Consulting Sterling, United StatesJob DescriptionJob Description · Title:Construction Quality Assurance Manager · Responsibilities · Daily onsite quality assurance oversight of construction trade subcontractors · Support development of quality checklists and forms to verify compliance with design drawings and ...
-
Quality Risk Management Specialist
3 weeks ago
Cintel Inc Sterling Heights, United StatesJob Description · Job DescriptionSalary: · Position Title: Quality Risk Management Specialist · Location: Sterling Heights, MI · Position Type: Full-Time · Cintel is a leading defense contractor dedicated to providing innovative solutions for the defense industry. We are current ...
-
Quality Manager
2 weeks ago
Specialized Recruiting Group - Michigan - Rochester Hills, Troy, Clinton Twp Troy, United StatesOur Tier 1 automotive supplier in Troy, MI is seeking an experienced Quality Manager to lead our quality management system and drive continuous improvement across the plant. This is an outstanding opportunity to join a growing, team-oriented organization dedicated to delivering e ...
-
Manager, Quality
3 weeks ago
RXO Warren, United StatesAccelerate your career at RXO. · RXO is a leading provider of transportation solutions. With cutting-edge technology at the center, we're revolutionizing the industry with our massive network and commitment to finding solutions for every challenge. We create more efficient ways ...
-
Quality Manager
3 weeks ago
International Automotive Components Warren, United StatesDirecting the performance of all Quality Assurance functions. Establishing quality standards and guidelines for manufactured products and processes. Ensuring compliance with all customer quality standard requirements. Representing the company in quality-related matters with custo ...
-
Quality Manager
3 weeks ago
MMI Engineered Solutions Warren, United StatesSummary of Position:Are you a seasoned Quality Manager looking for a dynamic opportunity in the automotive industry? MMI is seeking a dedicated individual to join our team as a Quality Manager at our Warren location. The Quality Manager will collaborate with leadership to develop ...
-
quality manager:
3 weeks ago
Pioneer Plastics Inc. Dba Pioneer Molding Inc. Warren, United StatesQUALITY MANAGER: Responsible for development of company's quality strategy, establishing QC control standards, processes, and metrics, identifying potential quality risks and issues, conducting internal and external quality audits to assess compliance, and driving continuous impr ...
-
Quality Manager
3 weeks ago
U.S. Farathane Troy, United StatesDiversity is an integral part of our corporate culture and success at USF. We welcome all individuals. · Quality Manager · Location: Troy, MI, 48084 · Job Description · The Quality Manager will be responsible for ensuring that all products and services meet the company's qual ...
Quality Manager - Sterling, United States - Resonetics
Description
Resumen:
The Quality Manager provides customer-and factory-facing quality support for contract manufacturing of medical device components at a specific Resonetics site. The position includes managing the interface between Resonetics and customers supplier quality organization, assisting with transition and sustaining of manufacturing processes, and support for supplier quality management.
The Quality Manager also acts as the lead person for a manufacturing site for all Quality and Regulatory matters and supervises other quality personnel on site. The Quality Manager oversees the site Quality department budget, Quality personnel hiring for the site, and establishes site-level policies to comply with Resonetics-wide directives. The Quality Manager is responsible for implementing new and revised corporate quality systems documents.
The Quality Manager is the Resonetics site Management Representative and leads facilitation of external audits. The Quality Manager position uses Quality Engineering techniques including: Problem solving using Lean Six Sigma methodology, Process Validations, Process Development and optimization, Gage R&R, reducing dependence on inspection, and ISO compliance.
Responsabilidades: