ROLE SUMMARYThe Senior Supplier Quality Engineer provides oversight, component/issue evaluation, and corrective action of all production and supplier quality related issues for external supplier processes and suppliers based on commodity class assigned. Generates reports, memos, files, and presentations necessary to manage the issues according to site procedures. Create, schedule, execute and summarize Quality Engineering related protocols. Assist in the process of gathering, interpreting and applying statistical methods to various Production/Quality related processes and communicating through reports, memos, files and presentations. Assist in training personnel on unique defects, protocols, measurement techniques and procedures. Owner for Quality System records within Change Management, Investigations, SCAR, and Commitment Tracking modules.
ROLE RESPONSIBILITIES- Designs and executes Quality Engineering related protocols; summarizes studies to ensure consistency of data production and compliance with manufacturer and Kindeva specifications/requirements and with current Good Manufacturing Practices.
- Responsible for quality and process related issue management for suppliers/vendors.
- Responsible for applicable process documentation to provide production process control ensuring performance within validated parameters.
- Owner for assigned projects, responsible for project management and task execution.
- Knowledgeable with statistical analysis using control charts, process capability, hypothesis testing, Gage R&R, ANOVA, and design of experiments. Familiar with using MINITAB.
- Analyzes data and issues memos, reports, and presentations concerning Quality Engineering projects or areas of interest.
- Evaluates equipment or process problems and designs testing and investigation plans to determine possible causes or solutions; assists in determining process capability of new equipment. May also be called on to harmonize measurement techniques between the site and supplier.
- Ensures product development activities have all necessary Quality Engineering support.
- Interacts with third party customers, outside testing laboratories and provides Quality Engineering assistance where needed on specific issues.
- Assists in identifying root causes and coordinates corrective action to quality issues.
- Ensures product or component traceability and quarantine as necessary.
- Assist QCD lab supervisor with technical issues involving product functionality, component testing, and protocol execution.
- Assists in compiling quality data including gage R&R studies, process capability studies, first article inspections, trending of product defects, trending of functionality data for finished product, dimensions on components or finished product, raw material inspection/sampling, incoming component inspection.
- Owner of Quality System Records, including but not limited to: SCAR, Change Management, Commitment Tracking, MIR/QAR/ER, MDCP CAPA, Action Items, Interim Report.
- Perform other duties as assigned by management.
PHYSICAL/MENTAL REQUIREMENTS- While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear; ability to lift up to 25 lbs.; sometimes exposed to loud noise.
- Work independently, with minimal supervision, under strict time guidelines; Stress (system owners/users expect immediate attention to and resolution of problems); Flexibility/organizational skills; speed and dexterity required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS- Position requires onsite attendance.
- Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
- Must have the ability to work effectively under and manage to strict production, time and performance deadlines.
- Must have the ability to travel 10% to visit suppliers in US and International locations as needed.
EDUCATION/EXPERIENCE REQUIREMENTS- BS in an Engineering related field, with a minimum of 2 years of medical device or pharmaceutical Quality Engineering related experience.
- Process and Material Skills: Familiarity with some of the following manufacturing processes - medical device glass cartridge or vial, plastic injection molding, rubber compounding and molding, printed labels and packaging. Familiar with various measurement gages used in Quality labs, knowledge of various types of mechanical testing.
- Thorough knowledge of cGMPs. Good working knowledge of associated industry and regulatory guidance documents, FDA guidelines, ISO standards, ASTM standards, etc. Excellent knowledge/understanding of protocol acceptance criteria and capable of determining appropriate Corrective Action/Preventive Action (CAPA) for recommendation to management.
- Certified Quality Engineer, Six Sigma training or Lean Manufacturing training preferred.
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