WORK SHIFT
DAY (United States of America)

SUMMARY OF DUTIES
Provides complex quality engineering work for specific product lines under broad supervision and guidelines. Basic responsibilities include: 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, and optimizing and improving quality systems and documentation.

ESSENTIAL FUNCTIONS PERFORMED

1. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.
2. Investigates a moderate number of engineering variables in completing assignments that have clear and defined objectives.
3. Works independently on standard projects while assistance is furnished on unusual problems.
4. Responsible for risk management documentation for assigned product line(s) or processes; identifies and updates failure modes and related process/product improvements by facilitating teams and implementing required changes.
5. Reviews, approves and generates Engineering Change Notifications (ECNs) to update or generate: verification, validation, monitoring and inspection methods, procedures, and test protocols; specific to assigned product line(s) and processes and production control(s).
6. Evaluates and participates in the selection of suppliers by monitoring supplier performance, through collection and trending of data and performing supplier quality audits, as required.
7. Reviews nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.
8. Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.
9. Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of: quality policy, quality objectives, audit results, analysis of data, etc.
10. Evaluates the work environment in which product is manufactured, and ensures it is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls.
11. May participate in design and development activities.
12. Performs other related duties and tasks as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
• Lifting -- Not to exceed 50 lbs. - local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Vision
• Color perception
• Depth perception
• Reading
• Field of vision/peripheral
• Fine motor skills
• Noise
• Chemical vapors

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 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.
• 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:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.