CORE RESPONSIBILITIES (Other duties may be required as assigned)
- Provides technical support to the IQC team through the development of robust inspection standards, fixtures, and CMM programs.
- Executes ¬Gage RR and component process capability studies for new and existing components.
- Develops and performs test method validation.
- Develops and implement SPC processes where appropriate.
- Provides inspection SME input to the development teams as part of the Design process.
- Overall management of the Nonconforming Material process.
- Leads effective MRB meetings to communicate trends and provide actionable insight into manufacturing quality processes.
- Performs root cause investigation as required and verifies material dispositions are executed.
- Develops, generates, and reports quality KPIs to the management team.
- Responsible for the implementation and management of the electronic Equipment Maintenance and Calibration systems.
- Provides feedback to engineers during the design, qualification, and validation activities of new test equipment and fixtures.
- Works closely with operators, technicians, and engineers to identify and implement IQC, In-Process, Calibrations and Equipment Maintenance improvements.
- Performs routine manufacturing quality process audits per applicable ISO13485:2016 standards and communicates findings to management for the creation of CAPAs and/or project teams.
- Updates controlled documents through the Engineering Change Order process.
- Maintain trained status for, and comply with, all relevant aspects of the Quality Management System to ensure product and support regulatory compliance
- Understand and adhere to the Company Quality Policy
- Understand and adhere to the Company EHS Policy
QUALIFICATIONS (Education, Experience, Certifications)
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- STEM degree from an accredited 4-year university (Mechanical, Biomedical, Manufacturing, or Industrial background preferred)
- 3-4 years of experience in Operational Quality role in a regulated industry (Medical Device preferred)
- Experience interpreting component drawings including GD&T.
- Strong knowledge of Production, Nonconforming Material, and Equipment Management Processes
- Understanding of ERP and PLM/QMS systems
- Excellent Excel, Minitab/JMP, and PowerPoint skills
- Familiarity with SolidWorks or other modeling software.
- Experience in a high volume medical device manufacturing environment preferred
- Knowledge of the following Medical Device standards: ISO 13485 & FDA (21 CFR Part 820), MDR, and MDSAP.
- Leadership skills to motivate and enable cross-functional personnel in meeting objectives, risk-based decision making, timeliness, personal accountability, and product/process compliance.
PHYSICAL DEMANDS
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- To perform this duty the employee must have the ability to sit or stand at and operate a computer terminal and walk or travel safely within the facility. The employee may occasionally lift and/or move up to 15 pounds.
- Work Environment
- While performing the duties of this job, the employee regularly works in an office environment.
Job Type: Full-time
Pay: $45,000.00 - $100,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Schedule:
Ability to commute/relocate:
- Redwood City, CA: Reliably commute or planning to relocate before starting work (Required)
Experience:
- Medical device: 5 years (Required)
- Quality Assurance Managers: 5 years (Required)
Work Location: In person