Senior Manufacturing Quality Engineer Jobs

Knowledge of Agile/Scrum/Kanban development processes

Defining automatic tests for the whole environment

Implementing or identifying relevant test cases (acceptance, integration, etc.)

Sharing the automation sets and tools with the rest of the development team

Analyzing test results, preparing summary reports, and providing fixes/improvements to the team based on that feedback

Carrying out both testing tasks and development tasks

Excellent and Affordable Benefits Package - Medical, Dental, Unlimited PTO, and 401K Match

7-10+ years of experience as a Manufacturing Engineer

Experience with assembly, forming, machining, and stamping processes

Some experience with machining/CNC programming would also be a plus

Develop, implement, and lead Capital Project activities

Design Tooling and Fixtures for increased productivity

Project management experience is required

8+ years' experience in equipment-intensive ISO 9000 manufacturing

Plastics processing experience is a plus

Develop, implement, and validate manufacturing processes for existing and new products

Lead verification and validation exercises for commercial manufacturing launch

Address non-conformances through NCR/CAPA system, escalating when necessary

Involved in equipment design and equipment process design, and will help take equipment from requirements to functioning machinery

Partner with vendors, R&D, and Product Development teams to develop timelines for new equipment and characterize process requirements

Assist and/or lead developing requirements and build outs of new processes and equipment

6 or more years of manufacturing experience, with 2 or more years in a Manufacturing and/or Process Engineering role or similar

Previous Equipment Design or Equipment Process Design experience

Strong communication skills, written and verbal

Knowledge of statistics, design of experiments, sampling, gauge R&R, FMEA/risk management and process control.

Intermediate to advanced knowledge of MS Office Suite and statistical software, Minitab experience preferred

Knowledge of applicable regulatory standards, specifically ISO 13485 or possess the ability to understand and enforce the practices.

Knowledge of ISO 17025 and FDA Regulation 21 CFR Part 820 is a distinct advantage

Strong problem solving and analytical skills, with concentration on risk analysis;

Demonstrated project organizational skills required

Project management skills. Use of PMO tools

Preferred industry experience: third party logistics, drug distribution, PBM, and/or distribution finance, manufacturing quality

Manage KPI reporting and program scorecards to monitor program performance, identifying and actioning opportunities for improvement.

Use data to identify opportunities and drive operational improvement, in partnership with the Account / Program Manager

5-7 years of experience of directly leading initiatives for a fortune 500 company

Working knowledge of ISO, IATF (TS), CGMP, CAPA or other quality processes

Manage process verification and validation activities according to FDA and all other global regulatory agency requirements

Participate with Supply Chain to select suppliers, manage the audit and qualification of new suppliers

Essential Job Duties & Responsibilities

Establish and implement effective process controls and product test requirements

6+ years of experience working within the medical drug/device regulated industry (e.g. FDA, ISO)

Demonstrated ability to effectively manage multifaceted projects and to resolve complex quality-related issues

Experience with NADCAP quality management system requirements for composite molding and bonding

Experience with AS9100 quality management system

Be able to make technical, data-driven decisions and execute with limited management support

Understand, follow and adhere to corporate Quality Management System on a daily basis.

Experience with Minitab, Made to Manage (or other ERP systems), and ply nesting software (Cutworks, Patternsmith, etc.),

Create production planning in Made 2 Manage ERP system, Item Masters, Bill of Materials, Routers, etc.

Estimate production times, staffing requirements, and related costs to provide information for management decisions.

Confers with management and other staff regarding manufacturing capabilities, production schedules and other considerations to facilitate production processes.

Excellent written and verbal communication skills. Prior experience in technical writing and procedure development.

Prior experience in machine shop practices including milling, turning and grinding a plus.

Previous experience with automation a plus.

Experience with mechanical design using SolidWorks.

Prepare various quality report for management review

Implement risk assessment and management of change in process

Drive Plant Quality performance metrics

Maintain compliance of the production site to all applicable regulatory, company and quality standards

Ownership of production related non-conformance, including Containment, investigation, and implementation of sustaining countermeasures

Operationalize QMS policies/procedures/WI/control for production operations

Strong knowledge and experience in injection molding processes is highly preferred.

Experience with quality standards and regulations, such as ISO 9001 and/or other relevant certifications.

Stay updated on industry trends, advancements, and regulatory requirements related to quality engineering and injection molding processes.

Excellent problem-solving and analytical skills, with a keen attention to detail.

Strong communication and interpersonal skills to collaborate effectively with cross-functional teams and external stakeholders.

Ability to work independently and manage multiple projects simultaneously.

2+ years’ experience in Process/Manufacturing Engineering or Quality Assurance in plant environment.

Process improvement knowledge in a manufacturing environment such as Lean Manufacturing, Six Sigma, etc.,

Six Sigma Green Belt training or certification required.

BS in Engineering or science field preferred.

Quality Process Engineer (Manufacturing) - Best in Class Manufacturing Company!!

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Collaborating with operations managers to develop and implement controls and improvements.

Lean Six Sigma Black Belt Certification preferred.

Developing and implementing quality standards.

Developing and implementing quality control systems.

Monitoring and analyzing quality performance.

Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met.

Provide technical support to customers, suppliers, and government agencies to guarantee compliance to contract requirements.

Lead the analysis of contractual requirements and creation of program plans, procedures, Quality Codes, etc.

Bachelor’s degree in an engineering/analytical/scientific field or equivalent experience

6 years minimum experience in a Quality related environment, 8+ years preferred.

If you're interested, you would need to meet the following requirements:

Function as the Quality lead for assigned program(s)

Demonstrated commitment to maintaining professional competence, knowledge, and skill necessary for fulfilling assigned responsibilities.

Deliver training and coaching on quality-related matters to production associates and management.

Present project updates utilizing the A3 project management process/format.

Prior experience in Manufacturing Quality Engineering.

Strong computer skills, including proficiency in Word, Excel, and PowerPoint.

Excellent team player with exceptional written and verbal communication skills.

Supply ongoing support to operations including risk management.

Development of appropriate inspections and requirements for complaints, Non-conformances and CAPA investigations

3-5 years experience in the field – manufacturing experience ideally

Responsible for ensuring compliance with the FDA QSR and ISO 13485.

Take part in technical discussions and contribute to risk-based decisions.

Conducts the implementation of CAPA systems, quality assurance plans, and process controls.

·Strong analytical, problem-solving, and project management skills.

·Ability to prioritize and manage time effectively.

·3+ years of experience in manufacturing, process engineering, supply chain, or quality field.

·Experience in an enterprise-wide reporting system is preferred.

·Certified Quality Engineer, Six Sigma Green Belt, or Quality Auditor Certification.

Quality Engineer - Advanced Battery Manufacturing | Briggs & Stratton

Assure business continuity in leadership positions and critical roles through talent management planning and development.

Must be articulate and able to communicate effectively with Corporate Officers, DVPs, directors, managers and employees across the corporation.

Possess substantial knowledge of FDA/International guidelines for device.

Career development with an international company where you can grow the career you dream of

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

An excellent retirement savings plan with high employer contribution

Skills, Experience, Education, & Training:

• Minimum 8+ years of progressive hands-on experience; or equivalent combination of education and experience.

• Experience gathering/processing internal and external requirements.

• Strong interpersonal and communication skills

• Knowledge of Quality Systems Regulations (21 CFR 820), ISO 13485 and ISO 14971 preferred.

• ASQ certification (CQE) is a plus.

• Identify, communicate, and control product and process risks for risk management reporting.

• Enhance quality system processes as it pertains to the management of assigned deliverables to ensure compliance.

• Generate monthly and quarterly data analysis reports for management visibility.

• Strong experience with complex medical systems containing software, hardware, and disposable.

• Working knowledge of ISO 13485 and ISO 14971.

• Experience in working with hazard analyses and risk analysis tools, such as FMEA, and FTA.