Werfen North America · 1 week ago
Senior Supervisor, Quality Control - Incoming Mechanical Inspection
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$100K/yr - $125K/yr
12+ years expWerfen North America 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 materials, ensuring compliance with procedures, and directing QC staff. This role requires advanced knowledge of mechanical inspections and involves training staff and managing QC production deadlines.
Health CareManufacturing
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
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
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 North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America 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)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
Company data provided by crunchbase