Supervisor - Quality Assurance

RRD is seeking a skilled Quality Assurance Supervisor for our Houston TX facility! 

Job Summary

Plan lead and coordinate all areas of Quality Assurance Services to exceed internal and external customer expectations in safety quality productivity schedules and employee relations. The ideal candidate will organize and control the processes procedures policies and activities for the assurance of the quality of the products according to the guidelines established by our clients and in compliance with the ISO 9001: 2015 and ISO 13485 reporting to Director Quality and Regulatory Affairs.

Responsibilities

• Plan and implement programs that ensure quality according to the requirements and guidelines of customers and in compliance with quality standards.
• Helps drives the culture of continuous improvement.
• Oversees a team that includes software quality engineering quality trainer and quality specialists.
• Assist with the preparation updating in the system of quality documentation basing the processes on the standard of ISO 9001: 2015 and ISO 13485:2016 and FDA.
• Supports the risk based approach to the site QMS and operations. 
• Communicate effectively with all internal external customers to ensure that all production requirements schedules quality and final deliveries of our products are satisfactory.
• Regularly ensure manufactured products are appropriately licensed produced and marketed.
• Foster the continual use and implementation of the philosophies and tools that are taught through our Total Quality Program.
• Perform the proper evaluation investigation and response to customer complaints.
• Make recommendations directly with manufacturing staff on the testing or trial usage of any new or alternate products and methods affecting product quality.
• Maintain daily communication with the Departments to follow the established processes and together take actions for the improvement or problems solution detected in the product or in the processes.
• Responsible to follow up and ensure that the personnel of the Department have the proper training to perform the job duties.
• Ensures adequate operational quality controls are developed to incorprate customer and regulatory requirements.
• Perform other related duties as required.

Qualifications :

• At least six years of experience working in a Quality Assurance or similar role with an Associates degree in a related field OR at least four years of experience working in a Quality Assurance or similar role with a Bachelors degree.
• Experience in medical device manufacturing or similarly regulated environment is preferred.
• Must be confident in their ability to make decisions balancing business requirements with quality requirements and the associated risks.
• JD Edwards or an ERP system experience is a plus.
• Excellent oral and written communication skills.
• Knowledge in ISOand 21 CFR820 is strongly preferred.
• Must possess skills to make presentations to top management.
• The incumbent is required to demonstrate a positive attitude on a consistent basis when working with others.
• Ability to work in matrix management and able to work collaboratively and cross- functionally as well as across the organization.
• Problem solving ability through technical knowledge.
• Must be able to multi-task and prioritize workload.

Certification in ISO 9001 & 13485 desirable.

Additional Information :

RRDs current salary range for this role is $67800 to $105800/ year. The salary range may be adjusted based on the applicable geographic location of the hired employee and the range may change in the future. At RRD it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions may vary based upon but not limited to education skills experience proficiency performance shift and location. Depending on the role in addition to base salary the total compensation package may also include participation in a bonus commission or incentive program. RRDs benefit offerings include medical dental and vision coverage paid time off disability insurance 401(k) with company match life insurance and other voluntary supplemental insurance coverages plus parental leave adoption assistance tuition assistance and employer/partner discounts.

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RRD is an Equal Opportunity Employer including disability/veterans