Senior Supervisor, Quality Control - Incoming Mechanical Inspection

Job Information

Number

ICIMS-

Job function

QA&RA

Job type

Full-time

Location

San Diego - WBH - 6260 Sequence Drive San Diego, California 92121 United States

Country

United States

Shift

1st

Introduction

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors.

Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

The Senior Incoming QC Lab Supervisor is responsible for overseeing all QC activities related to verification of requirements of incoming, in process, finished good materials, ensuring compliance with company procedures, work instructions and inspection plans and directing the QC staff as required to execute all required tasks. The Senior Incoming QC Lab Supervisor is also responsible for staff training and resource utilization.

They should have advanced knowledge of mechanical inspections, processes, equipment, GD&T, and blueprint reading.

The salary range for this position is currently $100,000- $125,000 annually. Individual compensation is based on the candidate s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs.

Key Accountabilities

• Experience with receiving inspections.
• Mechanical inspections, processes, equipment, GD&T, and blueprint reading.
• Ability to develop complex QC inspection methods.
• Superior QC technical skills.
• Experience working with measuring tools such as calipers, micrometers, or height and dial gauges.
• Experience with vision systems such as micro-VU or keyence.
• Ability to lead and guide staff to ensure compliance with the company quality management system.
• Lead cross-functional efforts to resolve product performance issues and lead corrective actions to update Standard Operating Procedures (SOP) and training materials.
• Support the Material Review Board in the execution of approved dispositions of NCR material.
• Ensure department staff are technically capable and appropriately trained to their assigned inspection responsibilities.
• Manage QC production deadlines and schedules.
• Lead assigned CAPAs to successful completion.
• Creation of QC validation protocols and reports.
• Other duties as assigned.

Networking/Key relationships

• Operations
• Quality Assurance
• Quality Engineering
• Materials Management
• Document Control
• Research and Development
• Manufacturing Engineering

Minimum Knowledge & Experience required for the position:

• Bachelor s degree or equivalent combination of education and experience required.
• A minimum of twelve (12) years progressive Quality experience within a Good Manufacturing Practice (GMP) QC lab setting required.
• A minimum of two (2) years previous supervisory experience required.
• Previous experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device (IVDD) strongly preferred.
• Previous Quality Assurance experience within a 21 CFR Part 820 and ISO 13485 regulated environment required.

Skills & Capabilities:

• Strong written, verbal and presentation skills are required.
• Strong planning, organizational and time management skills.
• Ability to appropriately prioritize department duties including urgent matters.
• Demonstrated competence with interpreting requirements and applying standard quality control practices and methodologies to determine material acceptability.
• Clear understanding of ISO 13485, Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).
• The ability to train and mentor staff in complex inspection/verification methodologies.
• Strong understanding of process, gage and equipment validation requirements.
• Experience with Enterprise Resource Planning (ERP) system (such as SAP) preferred.
• Computer literacy required; good working knowledge of Microsoft Office programs required.

Travel requirements: Less than 5%.

People Manager Core Competencies: Building Talent;
Planning and supporting the development of individuals  knowledge, skills, and abilities so that they can fulfill current or future job responsibilities more effectively;
Customer Focus;
Decision Making;
Driving for Results;
Driving Innovation;
Emotional Intelligence Essentials.

People Manager Accountabilities: Effectively carries out the expectations of…