What are the responsibilities and job description for the Sr. Design Quality Engineer position at OrthAlign Inc.?
OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Sr. Design Quality Engineer. This role supports design quality activities including design validation/verification, risk management including risk analysis and control, human factors analysis, as well as component qualification and CAPA investigations. Responsible for supporting on-market products, new product development, and continual process improvement initiatives.
You will:
- Work with Engineering, providing support with quality assurance input and review of design and development controls, specification development, test method development, usability engineering and risk management.
- Participate in design reviews and technical reviews and ensure these activities are performed per the standard operating procedure design validation and verification, design history file and device master record development and maintenance.
- Support/lead CAPA investigation teams associated with failure investigations including identification and completion of corrective actions.
- Identify, propose and drive opportunities for improvement, including review and revision of procedures, test methods, product design, and associated documents.
- Support audits of the quality management system, specifically relating to design control, risk management, CAPA, complaints, and related processes.
- Support regulatory submissions reviewing content for accuracy and comprehensiveness. Support other quality system activities as directed by management.
You need:
- To have worked in medical device quality with 7 years of experience or have a BS/BA degree with 5 years experience
- Strong proficiency using MS Office Suite (e.g., Word, Excel)
- Excellent written and verbal communication skills
- Results-oriented with appropriate urgency
- Ability to work as a collaborative team member as well as independently
- Excellent attention to detail, producing high quality output
- Flexibility and strong organizational skills with ability to prioritize multiple tasks
- Sound judgment when making decisions and communicating with peers and management
- Ability to read and understand technical documentation including engineering schematics, manufacturing instructions, and test protocols
- Good understanding of CAPA investigations and risk assessments
- Strong interpersonal relationship skills including negotiating and relationship management
- Experience in the development and performance of electronic medical device products design V&V testing (preferred)
- Experience with problem-solving methodologies including Design of Experiments, basic statistics, graphical analysis, hypothesis testing, and process mapping (preferred)
- ASQ Certified Quality Engineer (preferred)
We offer:
- Competitive compensation including bonus and equity
- Opportunities for career advancement
- Full benefits package
- An evolving, engaging culture and workplace
It is an exciting time at OrthAlign - make your next career move with us!
Please note that we are unable to provide any type of sponsorship at this time.
Salary : $115
