Supplier Quality Engineer
About The Position
The Senior Supplier Quality Engineer provides oversight, evaluates components and issues, and coordinates corrective actions for production and supplier quality issues involving assigned external suppliers and commodity classes. The role generates documentation and communications needed to manage issues under site procedures, and creates, schedules, executes, and summarizes Quality Engineering protocols. It also supports statistical analysis of production and quality processes, personnel training on defects and procedures, and ownership of Quality System records in several modules. The position manages supplier quality and process issues, supports production process control and product development, and leads assigned projects. It evaluates equipment and process problems, plans testing and investigations, analyzes quality data, supports traceability and quarantine, and works with customers, external laboratories, suppliers, and internal teams. The position requires onsite attendance and approximately 10% travel to supplier locations in the United States and internationally as needed.
Requirements
- Bachelor of Science degree in an engineering-related field.
- At least 2 years of medical device or pharmaceutical Quality Engineering-related experience.
- Familiarity with some manufacturing processes such as medical device glass cartridge or vial production, plastic injection molding, rubber compounding and molding, and printed labels and packaging.
- Familiarity with measurement gauges used in Quality labs and knowledge of different types of mechanical testing.
- Thorough knowledge of current Good Manufacturing Practices (cGMPs).
- Good working knowledge of relevant industry and regulatory guidance, including FDA guidelines, ISO standards, and ASTM standards.
- Excellent understanding of protocol acceptance criteria and ability to determine appropriate CAPA recommendations for management.
- Ability to work independently with minimal supervision under strict time guidelines.
- Ability to manage multiple capabilities, functions, competing priorities, and requirements simultaneously.
- Ability to work effectively under strict production, time, and performance deadlines.
- Ability to travel 10% to supplier locations in the United States and internationally as needed.
Nice To Haves
- Certified Quality Engineer certification.
- Six Sigma training.
- Lean Manufacturing training.
- Knowledge of statistical analysis methods including control charts, process capability, hypothesis testing, Gage R&R, ANOVA, and design of experiments.
- Familiarity with MINITAB.
Responsibilities
- Design and execute Quality Engineering protocols and summarize studies to ensure consistent data and compliance with manufacturer and Kindeva requirements and current Good Manufacturing Practices.
- Manage quality- and process-related issues for suppliers and vendors.
- Maintain applicable process documentation to support production process control within validated parameters.
- Own assigned projects, including project management and task execution.
- Analyze quality data and prepare memos, reports, and presentations about Quality Engineering projects or areas of interest.
- Evaluate equipment or process problems; design testing and investigation plans to identify causes or solutions; and assist in assessing new equipment process capability.
- Harmonize measurement techniques between the site and suppliers when needed.
- Provide Quality Engineering support for product development activities.
- Interact with third-party customers and outside testing laboratories, providing Quality Engineering assistance on specific issues.
- Assist with root-cause identification and coordinate corrective actions for quality issues.
- Ensure product or component traceability and quarantine when necessary.
- Assist the QCD lab supervisor with technical issues involving product functionality, component testing, and protocol execution.
- Compile quality data, including gage R&R and process capability studies, first article inspections, defect and functionality trending, dimensional data, raw material inspection and sampling, and incoming component inspection.
- Own Quality System Records, including SCAR, Change Management, Commitment Tracking, MIR/QAR/ER, MDCP CAPA, Action Items, and Interim Report.
- Assist in training personnel on unique defects, protocols, measurement techniques, and procedures.
- Perform other duties as assigned by management.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
