Sr Quality Systems Spec - Exempt

JOB DESCRIPTION

HM's Top Needs:

1. Customer-facing quality systems experience in a regulated environment

2. SAP-based order and shipment execution

1. Customer complaint/RMA and cross-functional coordination experienc e

The Senior Quality Systems Specialist will serve as the primary interface between and external customers for a designated business, while owning and optimizing the Quality Management System (QMS) processes that support customer-related activities. This role combines hands-on customer support (orders, changes, complaints, RMAs) with end-to-end responsibility for designing, maintaining, and improving quality processes, metrics, and documentation in alignment with ISO 13485 and FDA requirements.

Responsibilities may include the following and other duties may be assigned.

• Customer-Focused Quality Systems and Process Ownership

• Optimize and enhance existing Tempe frameworks that support customer-related activities to ensure alignment with ISO 13485, FDA requirements, and internal quality system standards.

• Establish, track, and continuously improve metrics and measurable indicators for customer-related processes (e.g., order performance, complaints, returns, turnaround times, service quality).

• Create, maintain, and revise QMS documentation (procedures, work instructions, forms, templates) required to support customer-related processes.

• Ensure audit readiness for customer-related quality processes and act as the subject matter expert (SME) during internal, external, and regulatory audits.

• Work with cross-functional and quality teams to develop, implement, and refine methods for collecting and reporting customer feedback and quality data.

• Customer Interface and Order Management

• Serve as the primary point of contact for assigned external customers, working with local groups on coordinating orders, changes, issue resolution, feedback/complaints, returns, and requests.

• Work with local planning team to accept forecasts and purchase orders from customers and create corresponding sales orders in SAP.

• Provide clear order acknowledgements to customers, leveraging SAP functionality where available and supporting configuration needs for the site as appropriate.

• Collaborate with Planning to obtain and confirm commit dates and communicate commitments to customers.

• Monitor drop shipments and coordinate with Planning to define transaction ownership (Planning vs. this role) in MES and SAP to ensure accurate shipment execution and documentation.

• Ensure SAP shipment transactions are completed accurately to generate invoices and shipping paperwork required by customers.

• Change Management and Customer Portals

• Partner with Engineering and other internal stakeholders to understand and execute customer-requested changes (e.g., product, documentation, process, or configuration changes).

• Submit and manage changes through customer change portals, acting as a liaison to reduce administrative burden on Engineering and other technical teams.

• Ensure customer change requirements are accurately translated into internal actions, documented in the QMS, and reflected in relevant systems.

• Complaints, Returns, and Issue Resolution

• Field customer complaints, feedback, and requests for Return Material Authorization (RMA), ensuring timely triage, documentation, and routing within the quality system.

• Coordinate with Quality, Operations, Engineering, and other teams to investigate issues, drive corrective actions, and improve service quality.

• Provide regular status updates to customers on open issues, complaints, and RMAs, ensuring a high level of transparency and responsiveness.

• Cross-Functional Collaboration and Reporting

• Develop and maintain strong working relationships with internal stakeholders (Quality, Engineering, Planning, Operations, Finance, Commercial teams) to resolve issues and drive process improvements.

• Track and report progress against objectives for customer-related quality initiatives, providing in-depth analysis and recommendations for process improvements.

• Work with Finance to provide accurate billable hour and cost information and support other customer-related financial tasks as needed.

Nice to Have:

• Experience with SAP (sales order creation, shipment transactions, and/or customer-related configuration).

• Familiarity with ISO 13485 and FDA quality system requirements.

• Experience with complaint handling, RMAs, or customer feedback systems.

• Prior experience in a role interfacing with Planning, Engineering, Operations, and Finance to support customer commitments and quality outcomes.

• Strong analytical skills with the ability to define, track, and interpret metrics for customer-related processes.

• Excellent communication skills and proven ability to collaborate with senior internal and external stakeholders.

Education Required:

• Requires a Baccalaureate degree

Years Experience Required:

• A minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours / week

Work Location:

Do they need to be local to any MDT office and if so where? Yes in person at Tempe, AZ

Does this person need to be on site? If so, full time or part time? YES, Onsite all 5 day s

Responsibilities may include the following and other duties may be assigned. Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external. Co-ordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.