Quality Engineer- Medical Manufacturing/Validation - Aptyx

OVERVIEW:

Assures acceptability of products, traceability, and accuracy of documentation. Performs various analytical auditing, inspection, and product support duties. Responsible for new tooling and component inspection, corrective actions, continuous quality improvement and gaging instruments. Works closely with quality functions and departments to reduce the variations in companywide processes and to assure quality products to meet all customer requirements. Substitutes in the absence of the QA Director.

RESPONSIBILITIES:

• Defines the quality plan, characteristics and design fixtures for new tooling and components inspection; interacts with customers and suppliers regarding decision making and problem solving; provides support of daily production and assures adherence to Qs procedures; takes corrective actions when necessary.
• Assures acceptability and traceability of product and accuracy of documentation.
• Performs various analytical, auditing, inspection, and product support duties.
• Set ups designing fixtures for measurements and reviews for continuous improvements.
• Assures adherence to document and quality specific procedures, and quality technical certification.
• Provides product inspection support at all levels in all molding and assembly departments, including incoming inspection and tool evaluation.
• Prepares first article data and characteristic accountability (PAPP)
• Reviews material and processing certifications
• Trains other personnel for quality related tasks.
• Attending training required and/or recommended to achieve benchmark quality performance.
• Performs work tasks in a quality manner to meet all internal and external customer requirements.
• Perform job in a safe manner and work towards achieving company safety goals.
• Substitutes in the absence of the QA Director.
• Recommends cost saving ideas and actively contributes to continuous improvement.
• Works to achieving department and company goals.
• Performs other related duties as assigned.

REQUIREMENTS:

• Performs all duties and responsibilities of a Quality Engineer and Inspector for measuring and inspecting all dimensions on tools or parts to determine conformance to print and/or customer requirements.
• Documents all inspections and maintains accurate files utilizing Master files.
• Recommends corrective actions on tools to meet print specifications.
• Performs audits on molded parts during the manufacturing process, purchased parts in receiving or final audits on finished products as required.
• Assist inspectors and set‑up personnel with inspection techniques.

• Gets involved in helping solve product/tooling problems as they appear, making recommendations for change or adjustments.
• Working knowledge of and proficiency with MS Office programs, Word, Excel and Power Point and Outlook.
• Performs audits on manufacturing production as assigned.
• Ability to work with minimal supervision and work cooperatively with others in stressful situations attends required training to achieve benchmark quality performance.
• Assist with training of employees to perform quality tasks to meet quality production.

• Assist in ISO audits or Customer Audits.

TRAINING:

• Thorough knowledge of quality assurance policies, inspection procedures and techniques, measuring equipment related to tool evaluation and product layout inspection, statistical analysis.
• Knowledge of the principles of molding, SPC, Kaizen, PPAP, APQP, ISO 9001 audits, ECN, PGA, GD&T, CMM and VMM machines, computer applications, special processes, machining and plastic molding injection.
• Excellent math skills and understanding of Statistics as they apply to measurement.
• Good written and verbal communication skills, computer skills (Words, Excel, Outlook, etc...)
• Good Problem-Solving skills.
• Proficient in Blueprint interpretation and full understanding of GD&T.
• Ability to work with minimum supervision and to work cooperatively with others in stressful situations.
• Teaching others is a key part of this job to improve performance.
• Ability to maintain accurate records and document data.
• Understands and utilizes many automotive tools, Control Plans, PPAPP process, Gauge R&R, Capability Studies, PFMEA's.
• Understanding Gear Data and measurements is a plus.
• Ability to write IQ, OQ and PQ Medical Protocols and Reports.
• Ability to write and pull together PPAP Reports for Customers.
• Ability to understand, modify, recommend, and improve measurement techniques as they relate to inspection or lab measurements.
• S degree in Quality or Mfg. Engineering plus 10 years of related experience in manufacturing, plastic molding or equivalent.