Manager, Site Quality Leader

Summary Description

The Quality Assurance group is dedicated to ensuring product compliance in support of site Manufacturing and Operations. This includes managing critical Quality System elements such as CAPA, Control of Nonconforming Product, Change Control, and Quality Control, Validation, and Compliance. The team collaborates closely with Operations and Manufacturing Engineering groups to maintain high product quality, maintain compliance, and implement effective and efficient corrective and preventive actions as needed.

Essential Duties and Responsibilities

• Subject Matter Expert and leader for key Quality areas including Process Validation, Change Control, Control of Nonconforming Product, & CAPA, and Document Control.
• Assist or lead in the identification, investigation, root cause analysis, implementation, and effectiveness verification of CAPA.
• Assist or lead Control of Nonconforming Product process activities (e.g., disposition review/approval and containment action activities).
• Evaluate impact assessments and risk assessments related to CAPA and NCMR.
• Provide QA on-the-floor support to Operations, Manufacturing Engineering, and QC as needed.
• Support new product development and production (e.g., Change Control review and approval for New Product Introduction).
• Support validations for new and existing products, processes, and equipment (document/change order reviews and approvals).
• Assist in measurement methods, MSA, TMVs, and GRR.
• Lead Quality Representative on projects & meetings.
• Establish and maintain Quality Management System procedures related to areas of responsibility.
• Ensure compliance with cGMP, QSR, ISO13485, MDD/EU MDR, and other applicable regulations/standards.
• Lead audits for the Internal Audit program.
• Participate in FDA inspections, ISO Certification and surveillance audits, and customer audits.
• Identify and implement opportunities for continuous improvement.
• Collect and report metrics and data as required.
• Perform other Quality Management System related duties as required.

Desired Minimum Qualifications

• BS degree in Engineering, Math, or Science (Biology, Chemistry, Physics, Statistics, etc.) with 5+ years of working experience in Quality Assurance/Control.
• Minimum of 5 years' experience in a regulated industry, preferably the Medical Device Industry.
• Working knowledge of critical Quality System elements related to QA Engineering, including CAPA, Control of Nonconforming Product, Change Control, Validation, and Quality Control.
• Provide a high level of QA on the floor support to Operations, Manufacturing Engineering, and Quality Control.
• Strong Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).
• Experience with measurement systems and statistical techniques to support Quality Control.
• Experience leading CAPA investigations.
• Working knowledge of medical device regulations (including FDA QSRs, ISO13485).
• Experience in high precision machining processes is highly desired.
• Ability to communicate effectively (both written and oral) in English (or local language).
• Strong technical writing skills.
• Proficiency with the MS Office Suite, including Microsoft Visio and Project.
• Ability to consistently observe company policies and safety procedures.
• Demonstrated ability to work cross-functionally in a team environment.
• Ability to work independently with minimal supervision.
• Must treat others with respect, work with integrity and ethically, and uphold organizational values.