Senior Product Quality Engineer Jobs

Teaches others the technical and functional knowledge and skills needed to achieve results at the optimum level of performance.

Collaborate with cross-functional teams to determine business requirements.

Demonstrate leading edge knowledge of concepts and theories in own discipline.

Advanced knowledge of Java 10+.

Advanced knowledge of API architecture, design, scalability, and security.

Experience architecting, designing, and developing and consuming web services.

Work cross-functionality with project management, R&D, regulatory, manufacturing, and other quality functions.

Collaborate with project teams to define product requirements, support test method development and validation, and support Design Verification planning and reporting.

Demonstrated ability to balance academic and extracurricular commitments (i.e. work experience, clubs, volunteer activities, teams, etc.).

Must possess excellent analytical and organizational skills.

Must be proficient and have practical knowledge in Microsoft Word, Excel, and PowerPoint.

Skilled in presentation development and public speaking.

Working knowledge of ISO 9001-based Quality Management System requirements.

Support the continuous improvement of the Quality Management System. Define and improve required documentation and activities.

Ensure the execution of product and process requirements. Define and improve such requirements.

Working knowledge of mechanical and/or electrical manufacturing processes.

Experience in Engineering, Manufacturing, or Quality in aerospace/defense, automotive, medical device, or similar complex hardware.

Experience with low volume manufacturing

The entire aspect of customer complaint management

You have excellent organizational skills and can manage multiple tasks with varying deadlines

the entire aspect of customer complaint management

You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook)

Bachelor’s degree or equivalent experience required

Minimum of 1-3 years Nuclear Medicine/PET and/or medical device industry experience

Disability Benefits (short term and long term)

Supplemental benefit programs: critical illness/accident hospital indemnity/group legal

Joining our team comes with amazing perks and benefits:

Additional sick leave beyond what state and local law require may be available but is unprotected

Life and Accidental Death Insurance

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

Excellent organization and time management skills

Previous experience with quality control or analytical labs is not required but is preferred

Manufacturing experience, particularly in molding and extruding technologies, preferred, but not required

Ability to prioritize and manage multiple tasks throughout the workday

Technical skills, such as blueprint reading, preferred

Analyze and test first piece samples

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.

Strong project management skills and ability to support suppliers through the assessment/qualification process

Advise senior management on action plans for events related to product quality and safety

Green Belt or preferably Black Belt in Lean, Six Sigma, Process Management and/or Quality

Manage multiple priorities across several programs

Minimum of 10 years of progressively growing experience with a track-record of innovation in energy, industrial, aerospace, medical, or safety-critical industries

Outstanding interpersonal, verbal, written, and presentation skills

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.

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

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

Talk about product issues with plant manager and non technical personnel.

3 plus years of experience as an engineer in a manufacturing setting.

3 years of quality testing experience

1 or more years of value engineering experience

Research, evaluate, develop, and apply new processes and methods into products.

Establish and conduct testing routines.

Prior Gas Turbine component experience and knowledge preferred

Minimum of 2 years of manufacturing experience and or relevant intern or co-op experience

Strong oral and written communication skills.

Demonstrated knowledge of GE systems

Develop, maintain, and optimize quality control processes for Gas Turbine Aero package unit Assembly.

Maintain oversight and tracking of the existing Quality systems in Cyber and Testing.

Develop in-depth knowledge of a discipline. Use prior experience and acquired expertise to execute functional policy/strategy.

Demonstrated Investment Casting manufacturing knowledge and experience is advantageous to the role.

Role is responsible for supplier processes, from initial qualification, maintenance, and necessary improvement driven by business quality needs.

Minimum of 4 years of experience in Engineering, Materials Science or Quality related roles.

Demonstrated experience in manufacturing or supplier quality.

Demonstrated history of problem solving, root cause and corrective action methodology, data analysis, statistical analysis and quality experience.

Collaborate with cross-functional teams including Development, Product Management, and Operations to ensure high-quality software releases.

Lead and manage the Product Quality/Engineering team, providing technical guidance, mentorship, and fostering a culture of innovation and continuous improvement.

Proven experience (8+ years) in leading QA Engineering teams, with a focus on automation, data, and APIs.

Extensive hands-on experience in designing and implementing test automation frameworks using industry-standard tools such as Selenium, Cucumber, JUnit, TestNG, etc.

Strong knowledge of data testing methodologies, including data validation, ETL testing, data integrity checks, and data quality assurance.

Experience with database systems (e.g., SQL, NoSQL) and query languages for data testing.

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)

Astronics AES offers a competitive benefits package including:

Identifies and solves problem areas within NPI. Manages actions to minimize or eliminate probability of problems occurring

Process auditing, Internal Auditor certification - Preferred

Lean Six Sigma (Green Belt level skills or greater preferred)

Performs analysis of quality data to identify trends or anomalies and recommend updates or changes to company standards and procedures

Assures compliance to in-house and/or external specifications and standards