Senior Quality Assurance Engineer I

Summary Of Duties

Provides routine and 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

Conducts complete and conceptually related studies to approach technical problems, whereas the problems are difficult to define, require unconventional or novel approaches, and require sophisticated research techniques.

• Performs technical work where available guides and precedents contain critical gaps, are only partially related to the problem, or may be largely lacking due to the novel character of the project.
• Contributes techniques which are of material significance to solve specific problems and drive continuous improvement.
• Keeps abreast of new scientific methods, standards, regulations, and developments affecting the organization for the purpose of recommending changes to processes, systems or designs warranted by such developments.
• May plan, organize, mentor, and supervise the work of engineers or technicians on various engineering projects and quality system compliance issues.
• Responsible for coordinating risk analysis/management activities.

Essential Physical/Environmental Demands

• Lifting -- Not to exceed 50 lbs. – local practice may apply.
• Sitting
• Standing
• Bending
• Writing
• Sitting
• Standing
• Bending
• Reading
• Field of vision/peripheral
• Fine motor skills
• Noise
• Chemical vapors

Minimum Qualifications

• Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field with six years of quality engineering experience (to include experience in the development and implementation of effective quality systems).
• Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member.
• 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, such as applied statistics, lean manufacturing, Six Sigma, etc.
• Knowledge of applicable regulatory agency regulations.
• 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 handling deviations, investigations and CAPAs.
• Experience with MasterControl, SmartCAPA, Oracle and Crystal.

COMPETENCIES

• Engineering problem solving/decision making
• Techician supervision
• Special projects/ECN's/prototype creation
• NC causes/corrective actions/dispositions

Comments

• Infectious Control Risk Category II