Quality controller serp_jobs.h1.location_city

Job Description & Skill Requirement :

Knowledge of application of Regulatory requirement including ISO 13485, FDA and International requirements

Enhanced quality system requirements (QSR) throughout business unit by improving quality process and CAPA Closure

Implementing SICR- Supplier Initiated Change Requests (DCR, ECR, MCR) through Change management Process and as per ISO 13485 & CFR 21 Part 820 requirements

Presenting Supplier Initiated Change Requests to Change Management Board (CMB) for review & Approval

Review and Closure of Supplier Audit Non-Conformities as per NC & CAPA management System (Track wise)

Review of Supplier deliverables like MSA, SPC, GD&T, Process Validation, PPAP, FMEA etc.

Conducting Supplier's Pre-Assessment Audits with Sourcing & RAQA Leads.

Implementing Change Control Agreement (CCA), Audit Adoption, Self-Assessment Audit and Onsite Audit through organization procedure

Collaborates with cross-functional and suppliers' teams to address top quality issues.

Own identified supplier driven non-conformances and manage the timely closure of NC's within Trackwise.

Own or support identified supplier CAPAs and manage to timely root cause investigation, implementation and closure.

Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.

Participates and may lead in the creation and / or review of new or modified procedures.

Maintain KPIs for monitoring of supplier quality processes, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.

Applies statistical methods of analysis and process control to external operations.

Support manufacturing transfers to / from other plants / facilities, executing appropriate quality activities.

Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections / corrective actions

Act as point of contact for Internal / External Customer groups on key compliance issues related to assigned suppliers

Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes.

Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders.

Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.

Deliver continuous improvement activities focusing on supplier quality.

Participate in supplier audit program - planning, execution and closure.

Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers.

Ability to collaborate effectively with lead cross functional team

Qualification :

Bachelor's Degree in Engineering or Science-related field

5+ years' experience in quality, engineering, manufacturing, or highly regulated environment

Fluent in written, oral in English and

Understanding of US and International Medical Device Regulations.

Strong knowledge of Quality Concepts (e.g. Risk Management, NC / CAPA, Audits, Statistics).

Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.

Strong interpersonal skills, written, oral communication and negotiations skills.

Strong in critical thinking and "outside the box" thinking.

Highly developed problem-solving skills. Strong analytical skills.

Demonstrated ability to work independently and as part of cross-functional teams French