Manufacturing Quality Assurance Engineer III

Summary Of Duties

Provides complex quality engineering work for specific product lines under broad supervision and guidelines.

• failure investigation
• oversight/determination of disposition of nonconforming materials
• conducting and updating risk analysis documentation and processes
• defining/refining quality inspection plans
• performing data collection and trending for presentation of key metrics
• identifying and addressing supplier quality issues
• reviewing and generating validation/protocol data
• optimizing and improving quality systems and documentation

Essential Functions Performed Independently

• evaluates, selects, and applies standard engineering techniques, procedures, and criteria
• investigates a moderate number of engineering variables in completing assignments
• works independently on standard projects while assistance is furnished on unusual problems
• responsible for risk management documentation for assigned product line(s) or processes
• identifies and updates failure modes and related process/product improvements
• reviews, approves and generates Engineering Change Notifications (ECNs)
• evaluates and participates in the selection of suppliers
• reviews nonconformance records (internal/external)
• ensures containment (identification, segregation and reconciliation) of nonconforming product
• evaluates the work environment in which product is manufactured

Summary Of Minimum Qualifications

• Education and/or experience equivalent to a Bachelor's Degree in Chemistry or related field with five years quality engineering experience
• Strong interpersonal, organizational, and verbal and written communication skills
• Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards
• Proven ability to work effectively in a team environment through conflict resolution and negotiations
• Working knowledge of statistical methodologies, quality control and manufacturing tools
• Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs

Preferred Qualifications

• Medical device experience or equivalent experience in a regulated industry
• Experience with SmartCAPA, Oracle and Crystal Reports
• Experience handling deviations, investigations and CAPAs
• Experience in medical devices

COMPETENCIES

• Engineering techniques/evaluation/selection/application
• Engineering variable analysis
• Plans/surveys/structures/equipment
• Supervisory assistance
• Special projects/ECN's/prototype creation
• NC causes/corrective actions/dispositions

Comments

• Infectious Control Risk Category II