WORK SHIFT
DAY (United States of America)

SUMMARY OF DUTIES
Provides routine and complex quality engineering work for specific product lines under broad supervision and guidelines. 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. 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.
2. 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.
3. Contributes techniques which are of material significance to solve specific problems and drive continuous improvement.
4. 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.
5. May plan, organize, mentor, and supervise the work of engineers or technicians on various engineering projects and quality system compliance issues.
6. Responsible for coordinating risk analysis/management activities. This may include leading risk management analysis meetings, documenting results, following up to ensure risk mitigation and facilitating improvements.
7. 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).
8. Mentors and evaluates competency of Quality Auditors, Quality Engineers, and technicians, by providing training or other actions required to satisfy quality objectives.
9. 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.
10. Reviews nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.
11. Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.
12. 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, risk management, etc.
13. Evaluates the work environment in which product is manufactured, and ensures it is adequately controlled and monitored, with sufficient personnel and safety production controls.
14. May participate in design and development activities.
15. May support Internal Audit and supplier audit activities, performing audits, writing audit reports, and following up on effectiveness of corrective/preventative actions.
16. 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

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
• Technician supervision
• 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.