Senior Manufacturing Quality Assurance Engineer Job South Jordan area,Utah USA,Quality Assurance

WORK SHIFT DAY (United States of America)

SUMMARY OF DUTIES

Provides extensive and diversified quality engineering support for products and processes while completing projects in broad areas of assignment. Basic responsibilities include: quality/technical support, mentoring and training of quality assurance employees, failure investigation, disposition of nonconforming materials, conducting and updating risk analysis documentation, defining/refining quality inspection plans, performing data collection and trending of key metrics, and identifying and addressing supplier quality issues.

Ensures that Merit products are designed, tested, and manufactured in compliance with all applicable agency/internal quality requirements and optimizing quality systems and documentation.

Basic Responsibilities

Quality/technical support, mentoring and training of quality assurance employees
Failure investigation
Disposition of nonconforming materials
Conducting and updating risk analysis documentation
Defining/refining quality inspection plans
Performing data collection and trending of key metrics
Identifying and addressing supplier quality issues

Essential Functions

Conduct complete and conceptually related studies to approach technical problems that are difficult to define, require unconventional approaches, and need sophisticated research techniques.

Perform 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.

Contribute techniques of material significance to solve specific problems and drive continuous improvement.

Stay abreast of new scientific methods, standards, regulations, and developments affecting the organization and recommend changes to processes, systems, or designs as warranted.

Plan, organize, mentor, and supervise engineers or technicians on various engineering projects and quality system compliance issues.

Coordinate risk analysis/management activities, leading risk management meetings, documenting results, following up to ensure mitigation, and facilitating improvements.

Review, approve, and generate Engineering Change Notifications (ECNs) to update verification, validation, monitoring, and inspection methods, procedures, and test protocols for assigned product lines and processes.

Mentor and evaluate competency of Quality Auditors, Quality Engineers, and technicians through training or other actions required to satisfy quality objectives.

Evaluate and participate in the selection of suppliers by monitoring performance, collecting and trending data, and performing supplier quality audits as required.

Review nonconformance records (internal/external) to determine disposition, root cause, and need for corrective and preventive actions.

Ensure containment (identification, segregation, and reconciliation) of nonconforming product is performed to prevent unintended use.

Identify and implement changes necessary to maintain the continued suitability and effectiveness of the quality management system through quality policy, objectives, audit results, data analysis, and risk management.

Evaluate the work environment in which product is manufactured, ensuring adequate control and monitoring with sufficient personnel and safety controls.

Participate in design and development activities.

Support internal audit and supplier audit activities, performing audits, writing audit reports, and following up on effectiveness of corrective/preventive actions.

Perform other related duties and tasks as required.

Apply strong statistical analysis and evaluation skills.

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 (including 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, ISO 13485, ISO 14791, 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 Master Control, Smart

CAPA, Oracle, and Crystal.
Statistical…