Quality Systems Manager

The Role

The Quality Systems Engineer is responsible for leading the Quality Assurance organization and ensuring compliance of the Quality Management System (QMS). This person will also be responsible for inbound quality control and verifying new and existing products as part of the release to production process. In this role, you will gain in-depth knowledge of customer requirements, define and execute test cases and procedures to assess overall product conformance to requirements, and determine release readiness for deployment to production/field. Testing will be approached using a system level perspective (i.e. product as a complete solution) to evaluate hardware, software, networking components, and related interfaces. 

What you'll do:

• Ensure the integrity of the quality management systems and provide support during Corrective and Preventive Action (CAPA) activities.
• Oversee the company’s Internal Quality Audit system, including tracking and follow-up on all audit findings.
• Organization of quality data (Manufacturing, defect rates, etc) for trending and reporting.
• Support and/or lead 3rd party audits, including follow-up on actions.
• Partner with Process owners to generate metrics that can be easily reported on to identify areas of concern.
• Upgrade and manage the  Internal Quality Audit program.
• Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).
• Propose process improvement opportunities based on continued analysis and monitoring of metrics, goals and objectives.
• Generate/maintain procedures, work instructions and forms, as necessary to ensure standardization of practices.

Product Testing Responsibilities:

• Review requirements, specifications and technical design documents, and provide timely and meaningful feedback.
• Provide estimates for testing duration and related expenses to execute the validation and verification process. Assess performance against estimates and drive appropriate root cause corrective action for variances.
• Plan, coordinate, and execute testing activities; including preparing and executing detailed, comprehensive and well-structured test plans for functional and non-functional requirements as well as regression testing.
• Ensure defects/issues encountered during testing are thoroughly documented, analyzed with key stakeholders, and resolved in a timely manner.
• Actively participate in project meetings and represent customer needs throughout the gated product realization process.
• Work with design engineers to determine sampling locations and the validation of in-situ sensors used for product quality data
• Participate in continuous improvement activities and make recommendations to improve the product/supporting processes.

What we're looking for:

• Experience applying QA/test methodologies and tools; including traceability of requirements to test cases.
• Must be proficient in failure analysis and corrective action methods.
• Knowledge and application of FDA Guidelines/GMPs/OSHA and other regulatory requirements.
• Strong analytical and statistical skills.
• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written)
• Ability to exercise judgment to determine methods, techniques and evaluation criteria for obtaining results.
• Able to prioritize tasks and manage multiple projects at once in a fast paced environment.
• Must be proficient in Google Suite.

Preferred:

• BS degree (or equivalent in experience) required. Education in Engineering, Computer Science, or related Quality program.
• 5 years Quality Assurance / Quality Systems experience (FDA-regulated industry)
• Experience in developing, customizing and/or implementing relational database applications, for quality data tracking and trending (SQL, Access, SAP, BusinessObjects, AirTable etc.).
• Six sigma training/certification
• Experience and proficiency in setting up quality programs including sampling methods and escalation management
• Love for coffee!