Senior Engineer, Quality Assurance Engineering - Individual Contributor

• Work closely with operations and business functions to ensure quality performance of products and processes.
• Collaborate with internal cross-functional and supplier teams to address quality issues.
• Own and manage internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA) using Trackwise.
• Support execution and analysis of manufacturing-related complaint investigations and product field actions.
• Investigate and manage disposition of internal non-conforming products within MRB, issuing NCs as needed.
• Communicate and collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as necessary.
• Execute and manage Supplier Initiated Change Requests (SICRs), engaging with cross-functional teams for assessment and approval.
• Support manufacturing transfers to/from other plants/facilities with appropriate quality activities.
• Collaborate with stakeholders to identify and execute supplier part certification opportunities.
• Engage in the development and improvement of internal manufacturing and distribution processes for existing products.
• Perform critical assessments and qualifications of change management activities, including PPAP activities for supplier changes.
• Participate in and potentially lead the creation and review of new or modified procedures.
• Support the development and review of process and equipment validation/qualification and MSA of internal processes.
• Maintain KPIs for monitoring process and product quality, perform analysis, and interpret trends, taking appropriate actions as necessary.
• Perform other related duties as assigned.

• Minimum of 3 years of experience in quality assurance or related field.
• BA Degree in Science/Technical field or related field.
• Experience in CAPA and using Trackwise/ERP systems.
• Proficiency in MS Suite.
• Strong multi-tasking, communication, and problem-solving skills.

• Power BI knowledge is a plus but not required.
• CQE and/or LSSGB certification is beneficial.
• Previous medical device industry experience is desired with understanding of US and International Medical Device Regulations.
• Familiarity with GDP, GMP, and experience interacting with regulatory agencies such as FDA and TUV.
• Knowledge of key quality concepts such as Risk Management, CAPA, Audits, and Statistics.
• Project management, leadership, and influencing skills.
• Ability to manage multiple tasks simultaneously and complete projects in a matrix organization.
• Strong interpersonal, written, and oral communication skills.
• Highly-developed critical, problem-solving, and analytical skills.
• Ability to work in a fast-paced, dynamic, and time-critical manufacturing environment.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

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