Quality Engineer I
- Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance)
- Leads development of risk assessments and test methods
- Leads component qualifications, design validation / verification and process validation
- Support product investigations
- Ability to make and present risked based decisions
- Assess product changes against product design
- Supports translation of design inputs into manufacturing control plans
- Develop and implement procedures to comply with corporate and industry standards.
- Coordinates and/or directs all aspects of product development activity related to a product line
- Leads development of risk assessments and test methods
- Quality engineering representation on Product Development Teams
- Prepare and present project updates and technical discussions
- Participate in project planning, budgeting, scheduling, and tracking
- Support internal and external supplier audits
- Provide support to the regulatory department in writing technical submissions
- Complies with company procedures and policies, government regulations
- Ability to travel up to 25% of the time
- Other duties and projects, as assigned
- BS in Engineering
- 0-2 years' experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry.
- Knows how products are used and impact the user(s) so that risk can be managed effectively
- Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
- Ability to lead creation of risk management files
- Ability to develop solutions with business impact
- Statistical and risk assessment techniques
- Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies
- Ability to make and present risk-based decisions
- Strong interpersonal skills
- Ability to analyze and optimize manufacturing and quality systems
- Product, design & prototyping
- Ability to create and provide training
- Problem solving ability
- Ability to create, review and coordinate test protocols and reports
- Ability to generate engineering proposals
- Oral and written presentation skills
- Ability to Lead cross functional teams
- Understanding of regulatory requirements including ISO 13485, ISO 14971
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