Manager, Site Quality Leader

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

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.

Subject Matter Expert and leader for key Quality areas including Process Validation, Change Control, Control of Nonconforming Product, & CAPA (Corrective & Preventative Actions), and Document Control. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 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, ISO
13485, 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.

Note:

Other duties may be assigned as necessary.

The following qualifications represent the knowledge, skills, and abilities required for this position:

Education & Experience:

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. In addition, 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, ISO
13485). Experience in high precision machining…