Job DescriptionPlan, 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 clients and in compliance with the ISO 9001: 2015 and ISO 13485.
Responsibilities:
- Plan and implement programs that ensure quality according to the requirements and guidelines of customers and in compliance with quality standards.
- Oversee 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.
- 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.
- 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.
- Follow up and ensure that the personnel of the Department have the proper training to perform the job duties.
- Ensure adequate operational quality controls are developed to incorporate customer and regulatory requirements.
- Foster the continual use and implementation of the philosophies and tools that are taught through our Total Quality Program.
- Supports the risk based approach to the site QMS and operations.
- Helps drives the culture of continuous improvement.
- Perform other related duties as required.
Qualifications- Associates degree in a related field required
- Bachelor's degree in related field preferred
- At least six years of experience working in a Quality Assurance or similar role with an Associate's degree in a related field OR at least four years of experience working in a Quality Assurance or similar role with a Bachelor's degree.
- Must be confident in 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 ISO 9001, 13485 and 21 CFR820 is strongly preferred.
- Must possess skills to make presentations to top management.
- 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 InformationThe national pay range for this role is $73,500 to $116,000 annually. The pay range may be slightly lower or higher based on the geographic location of the hired employee. The actual pay offered may vary based upon, but not limited to: education, skills, experience, proficiency, performance, shift and location. In addition to base salary, depending on the role, the total compensation package may also include participation in a bonus, commission or incentive program. RRD offers benefits including medical, dental, and vision coverage, paid time off, disability insurance, 401(k) with match, life insurance and other voluntary supplemental insurance coverages, plus tuition assistance, maternity leave, adoption assistance, and employer/partner discounts.
- All your information will be kept confidential according to EEO guidelines.
- At least 2 years in product operations, data entry, or another similar support role.
- Strong analytical skills with the ability to identify trends and communicate insights.
- Clear communication skills for engaging with cross-functional teams and presenting insights.
- Problem-solving skills for straightforward situations using judgment and established guidelines.
- Ability to prioritize tasks and manage multiple responsibilities.
