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Werfen · 2 months ago

Senior Supervisor, Quality Control - Incoming Mechanical Inspection

US-CA-San Diego

Full-time

Onsite

Senior Level, Lead/Staff

$100K/yr - $125K/yr

12+ years exp

Werfen is a company focused on quality control in the medical device sector. The Senior Incoming QC Lab Supervisor is responsible for overseeing QC activities related to incoming and finished goods materials, ensuring compliance with procedures, and managing the QC staff to meet production deadlines and schedules.

Health CareHospitalManufacturingMedical Device

H1B Sponsor Likely

Responsibilities

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

Qualification

Mechanical inspectionsGD&TBlueprint readingQuality control practicesERP systemsTrainingProcess validationMentoringPlanningOrganizationCommunication skillsEmotional intelligence

Required

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 Quality Assurance experience within a 21 CFR Part 820 and ISO 13485 regulated environment required

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

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

Computer literacy required; good working knowledge of Microsoft Office programs required

Preferred

Previous experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device (IVDD) strongly preferred

Experience with Enterprise Resource Planning (ERP) system (such as SAP) preferred

Company

Werfen

Glassdoor4.0

Werfen is a developer, manufacturer and distributer of IVD testing solutions.

Founded in 1966

Barcelona, Catalonia, ESP

5001-10000 employees

http://www.werfen.com/

H1B Sponsorship

Werfen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (10)

2024 (12)

2023 (10)

2022 (2)

2021 (11)

2020 (8)