Branford, CT 06405 US
- Competitive salary of $65,000/year - $88,000/year annually, reflecting your expertise and technical skills
- Direct Hire opportunity: Enjoy stability, growth opportunities, and direct access to client’s benefits
- Onsite position: Be at the forefront of change and collaborate with a dedicated team onsite
- Join their team to embark on a career journey with ample room for growth and professional growth
- Bachelor’s Degree with at least two years of related work experience or the equivalent combination of education, experience, and training.
- A minimum of 2 years in quality within the medical device industry is required.
- ASQ (e.g., CQE, CMQ/OE, etc.) and Lean and Six Sigma certification are highly preferred.
- Knowledge of FDA Regulations.
- Knowledge of risk management, including key terms and definitions, assessment tools, and reporting.
- Technical knowledge of medical device process qualifications.
- Understanding of FDA QSR Part 820, ISO 13485, ISO 14971, EU MDD / EU MDR
- Applies knowledge of statistical process control principles and quality engineering techniques to influence manufacturing processes for current and future products positively
- Represents the Quality function in various roles such as supplier quality, supplier audits, and supplier Quality Agreements
- Provides quality input in assisting with generating Process Qualification plans, reviewing process inputs, outputs, verification, validation, phase reviews and scale-up strategies
- Supports review of Incoming Inspection drawings and inspection forms, First Article Inspections (FAIs) for new and existing components
- Drive continuous improvement initiatives to enhance overall product quality and operational efficiency
- Partnership with experienced recruiters that will advise you on all aspects of your job search and career aspirations
- Our network has direct access to hiring managers, and we will get your resume to the top of the pile of submissions for this opportunity and many more like this
- Long-term career partner who will provide you with market intelligence and guidance
- Industry competitive salary based on your experience/qualifications
- Health, Vision, and Dental Insurance
- 401(k) plan