Job description

Location: Menlo Park, CA – Hybrid Schedule 3 Days on-site

Length: 3-6 months-to-hire

Process: MS Teams Interview + on-site + possibly Director of quality sitting in Boston.

Start Date: ASAP

JOB TITLE: Quality Engineer

REPORTS TO: Head of Quality

JOB PURPOSE: Support product quality and quality management system initiatives

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Supports the implementation and maintenance of the quality system in accordance with all applicable regulatory requirements and provides guidance and training to employees to execute company policies, procedures, and systems needed to fulfill worldwide quality system requirements as a medical device manufacturer
• Carries out activities to support agreed business plans, budgets, products, and timescales
• Serves as Quality Engineering representative on design teams for new products, added indications for use, and design improvement projects
• Drives risk management activities (ensure compliant process)
• Reviews and approves design/process verification and validation protocols/reports
• Manages sterilization validation and on-going re-qualification (quarterly dose audits), Tracks and trends bioburden and sterility results
• Supports 510k submissions and responses
• Supports Operations with management of contract manufacturer, including review and approval of supplier change notifications and nonconformance reports
• Works with contract manufacturer and Operations to resolve quality issues in production
• Serves as CAPA Manager for corrective and preventive action programs
• Serves as Complaint Manager - Receives, evaluates, investigates, and responds to customer complaints
• Documents and submits adverse event reports
• Performs verification of effectiveness of implemented actions for CAPA, audit responses, etc.
• Supplier quality management
• Reviews and approves change orders related to the product design
• Supports Document Control personnel and processes
• Coordinates internal audits as required; Generates response to internal audit findings and assists with response to FDA 483s
• Conducts supplier audits as required
• Provide Quality System training as required
• Manages nonconforming material program
• Monitors and reports Quality activities; Performs data analysis in support of management review meetings and periodic metrics

QUALIFICATIONS

• Bachelor’s degree (BS) in an engineering field and ten or more years working in Quality for medical devices; or equivalent combination of education and experience

• FDA GMP regulations (21 CFR 820) and/or ISO13485 Experience

• 8-12 Years of Quality Engineering (Senior-level and/or prior QE Management experience is Preferred

• Attention to detail

• Critical thinking skills

• Proficiency with Microsoft Excel, Word, PowerPoint

Job Types: Contract, Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: One location

bottlesandcaps.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, bottlesandcaps.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, bottlesandcaps.com is the ideal place to find your next job.