Senior Supervisor, Quality Control - Incoming Mechanical Inspection

Werfenlife SA.; San Diego (CA); On-site; USD 100,000 - 125,000; Full time

Job summary

Werfen is seeking a Senior Supervisor for their Quality Control Lab to oversee QC activities related to incoming materials. The ideal candidate will possess extensive experience in a GMP environment, demonstrating leadership and strong mechanical inspection skills. This role involves managing staff, ensuring compliance with standards, and navigating complex QC procedures, contributing to innovative healthcare solutions.

Qualifications

• Minimum 12 years in Quality Control within a GMP lab.
• At least 2 years of supervisory experience.
• Experience in regulated medical device manufacturing.

Responsibilities

• Oversee QC activities related to incoming materials.
• Lead staff training and compliance with quality management systems.
• Create and validate QC protocols and reports.

Skills

Quality Control

Mechanical Inspections

GD&T

Blueprint Reading

Leadership

Planning

Organizational Skills

Education

Bachelor's degree or equivalent

Tools

Measuring tools (calipers, micrometers)

Vision systems (micro-VU, Keyence)

ERP systems (SAP)

Microsoft Office

Job description

Senior Supervisor, Quality Control - Incoming Mechanical Inspection

Country

United States

Shift

1st

About the Position

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.

Overview

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- $125,000annually. 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.

Responsibilities

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 managementsystem.• Lead cross-functional efforts to resolve product performance issues and lead correctiveactions 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 assignedinspection responsibilities.• Manage QC production deadlines and schedules.• Lead assigned CAPAs to successful completion.• Creation of QC validation protocols and reports.• Other duties as assigned.

Qualifications

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 DiagnosticDevice (IVDD) strongly preferred.• Previous Quality Assurance experience within a 21 CFR Part 820 and ISO 13485 regulatedenvironment 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 qualitycontrol 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 TalentPlanning and supporting the development of individuals’ knowledge, skills, and abilities sothat they can fulfill current or future job responsibilities more effectively.Customer FocusEnsuring that the internal or external customer’s perspective is a driving force behind strategic priorities, business decisions, organizational processes, and individual activities; crafting and implementing service practices that meet customers’ and own organization’s needs;promoting and operationalizing customer service as a value.Decision MakingIdentifying and understanding problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; choosing the best course of action byestablishing clear decision criteria, generating and evaluating alternatives, and makingtimely decisions; taking action that is consistent with available facts and constraints and optimizes probable consequences.Driving for ResultsSetting high goals for personal and group accomplishment; using measurement methods tomonitor progress toward goals; tenaciously working to meet or exceed goals while derivingsatisfaction from that achievement and continuous improvement.Driving InnovationCreating an environment (culture) that inspires people to generate novel solutions withmeasurable value for existing and potential customers (internal or external); encouragingexperimentation with new ways to solve work problems and seize opportunities that resultin unique and differentiated solutions.Emotional Intelligence EssentialsEstablishing and sustaining trusting relationships by accurately perceiving and interpretingown and others’ emotions and behavior; leveraging insights to effectively manage own responses so that one’s behavior matches one’s values and delivers intended results.

People Manager Accountabilities:Effectively carries out the expectations of Werfen People Managers as defined in Werfen’sRole of the Manager program. Among others this includes maintaining regular, at minimumonce a month, and transparent communication with the team through effective use of formal one-on-one meetings with direct reports and team meets. Managing performance issuesand conflict proactively; uses judgement in consulting with department leadership and Human Resources. Responsibility for the team´s compliance in terms of training, and fulfilmentof their tasks and objectives as well as onboarding of new employees and development ofthe existing team.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [e-mail] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.