Senior Manufacturing Quality Engineer Jobs

Full benefits: Medical, Dental, Vision

Ensure compliance with our regulatory standards

Perform and coordinate internal audits with Quality System Standards (ISO 9001)

Provide corrective actions to any products or process that is in nonconformance

Work directly with our suppliers to improve the quality of our materials

Competitive Base Salary - $60K - $85K

Measure and evaluate unit operation durations to implement optimal scheduling to meet facility and client requirements.

Seeks opportunities to improve process performance within process ranges defined by large-scale equipment capabilities.

Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.

Ability to effectively present information and respond to questions from groups of managers and clients.

Basic knowledge of computers and Microsoft Office software products.

Knowledge of quality concepts, supplier quality management, and manufacturing operations

Understanding of project management concepts. Direct PM experience a plus.

MS or BS in Engineering or Color Science required. Project management experience is a positive.

Experience with visual comparison and assessment of color and texture

Experience in developing quality plans or experience with color appearance, gloss and/or texture metrology preferred

Experience with any of the following: optical coatings, plating, anodizing, resin compounding, pigmentation, textiles, dyeing or color formulation.

Strong analytical skills, experience with project management tools, excel, and powerpoint required. Netsuite or other ERP system experience a plus.

Manage supplier certification / compliance tracking documents and ensure Certifications are current and accessible.

Manage corrective action requests and audit processes/controls with suppliers.

Manage/hire QC personnel as needed for onsite inspection/validation.

Investigate field/customer product quality complaints; and manage corrective actions

5+ years of experience as quality manufacturing engineer

10+ Years of successful experience in Manufacturing / Quality, focused on providing operational support to assembly operations.

Work with Design, Operations and Quality Leadership to prioritize funding/resources to meet targets, support Continuous Improvement.

Provide technical oversight to drive the development, sustainment and continuous improvement of factory quality.

Engineering degree with strong content tied to understanding and impact to business financial performance

Travel (up to 10%) to suppliers and other manufacturing locations as needed.

we always look for a better way

Lead lean manufacturing activities including Kaizens, 5S, Poke Yoke, TPM, Visual Management, Kanban, and others

5+ years of related experience

Experience managing capital equipment and new product projects from concept to implementation

Evaluate and review manufacturing processes and products

Implement corrective actions for manufacturing

Troubleshooting and support for internal and external projects

Experience with Medical Devices quality management systems standards (e.g. ISO 13485)

Gather quality metrics and analyze for trending and inclusion into Management Review and the CAPA process, as necessary

Maintain a thorough knowledge of current QSR and ISO requirements as they apply to the medical device industry

Assist with design transfer to ensure all requirements are effectively implemented within Operations

Assist manufacturing personnel to develop, establish and maintain work environment and infrastructure requirements

Responsible for equipment control, including preventive maintenance, calibration, and qualification activities

iota offers a very competitive benefits package that includes the following:

Responsibilities may include the following and other duties may be assigned:

Strong leadership skills to influence process improvement and change.

Incorporate inspection and test requirements into the production plan.

Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

Plan and execute qualification and validation activities (TMVs, IQs, OQs, and PQs).

Act as the voice of quality in the hardware change management process, ensuring quality requirements are considered and met.

Proficient communication and project management skills.

8+ years of work experience in managing manufacturing quality in the electronic industry.

5+ years of direct engineering experience in hardware system issue solving.

3+ years of direct GPU related engineering experience in issue debug/test log review.

OR Doctorate in manufacturing, material, mechanical, electrical, and industrial engineering, or related field AND 3+ years experience in a manufacturing environment/repair

Preferred Knowledge, Skills And Abilities

Provide required training to support qualification activities

Assume the QA responsibilities for reviewing and approval of validation life cycle documentation (PDD, IOQ/PQ protocols, protocol addendums, summary reports, etc.)

Keep current with all Industry standard practices and FDA requirements for validation, change control and complaint handling

Bachelor’s degree or equivalent experience in a technical discipline including Biology/Microbiology, Chemistry or Engineering

6 - 10 Years of experience

3+ years of experience working on AEC-Q100 product qualifications

Lead the Development and Launch of multiple aspects of the Quality Management System across Project Kuiper.

3+ years of OSAT quality, manufacturing or design engineering experience

3+ years of experience managing quality of OSAT / foundry supplier partners

Perform audit activities to ensure compliance to QMS requirements.

Lead MRB discussions determine product dispositions for nonconforming material.

Ability to maintain professional competence, knowledge, and skills necessary for fulfilling assigned responsibilities satisfactorily.

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

Report project progress using the A3 project management process/format.

Extensive experience in Manufacturing Quality Engineering.

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

Excellent written and verbal communication skills with a collaborative mindset.

Outstanding interpersonal and relationship management skills with the ability to effectively collaborate with varying levels of the organization

Excellent project management skills and the proven ability to manage multiple projects at any given

Communicate emerging issues for responsible components daily to Quality Systems Manager

Excellent written and verbal communication skills with the ability to distill complex subjects to a wider audience

Benefit options are not available for this role.

What will give you a Competitive Edge (preferred qualifications

Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.

Knowledge and experience with server hardware, or equivalent, or data center server and rack hardware.

Knowledge of server cooling design, power consumption, airflow and hands-on experience in power, airflow and power quality measurements.

Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.

Improves factory efficiency by analyzing and planning work flow, space requirements, and equipment layout.

Assures product and process quality by designing control systems, testing finished- product and process capabilities; establishing standards; confirming manufacturing processes.

Reviewing customer contracts to ensure specific requirements are met

5+ years of experience in a manufacturing environment

Must have working knowledge of ISO 9001

CQE or Lean Six Sigma certification

Oil and gas industry experience preferred

$85,000 - $105,000/year commensurate with experience

Coordinate audits of our facility as outlined within the Quality Management System in support of the applicable ISO Standards.

Improve response to ISO audits of our facilities to ensure conformance to requirements.

Manage internal audits that optimize plant operations.

Manage and coordinate activities of the process laboratory and laboratory colleagues.

Several years’ experience in managing quality systems and labs in an ISO 9001 environment.

Develop, implement, and improve effective Quality Control Methods and Procedures necessary to support ISO Quality System.

· Experience with equipment qualification processes, including IQ, OQ, and PQ, in a medical device manufacturing environment.

We offer a competitive compensation package to successful candidates.

· Provide guidance and training to manufacturing personnel on quality control methods, procedures, and best practices.

· Bachelor’s degree in engineering or a related field.

· Proficiency in process validation methodologies, including protocol development, execution, and report writing.

· Familiarity with statistical analysis tools and techniques used in quality control and process improvement.

Lean Manufacturing, 6-Sigma, Project Management knowledge/skills

Requirements/Preferences: Education Preferred: Bachelor’s degree in an engineering related field

Experience Preferred in following areas: Manufacturing Engineering, Quality Engineering, Industrial Engineering (open to recent graduates)

Top Must Have’s: Manufacturing Related Experience (Manufacturing Engineering, Quality Engineering, Industrial Engineering) or BS Engineering

Computer Skills: Including CAD, Office Suite/Power BI

Education Preferred: Bachelor’s degree in an engineering related field

Proven experience in Supplier management, involving document review, audits, PPAP, and SICR.

Proficient with ISO 9001:2015 standards, showcasing an understanding of quality management systems.

Quality Management Review: Actively participate in Quality Business Reviews (QBR) and Supplier Management Review activities.

Demonstrate a minimum of 4 years' hands-on experience in either wireless or medical device industries.

Exhibit excellent organizational and communication skills, both written and verbal.

Possess knowledge of manufacturing processes for molded plastic parts and electronics assembly of printed circuit boards.

· Experience in Data Engineering technology stack on AWS IoT Gateways, Splunk.

· Understand the vehicle production process, production line, quality engineering etc.

· Must collaborate with internal teams to produce software design and architecture

· Develop documentation – Create user stories.

· Serve as an expert on applications and provide support