Address
Form of work8500 Research & Development - Design Quality Engineer
Fort Wayne, IN, USA Req #1518
Wednesday, January 10, 2024
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer's quality specifications for each product we produce.
What You Will Do:
- Responsible for supporting a design control quality system that is complaint to ISO 13485 (latest revision), the Medical Device Directives (while active), and the EU Medical Device Regulations (MDR).
- Supports, reviews, and approves the following activities associated with new product development: identification and documentation of user needs, design inputs, outputs, verification, validation, risk assessment, and design change activities to demonstrate new product designs are supported by objective evidence in the design history file prior to product launch.
- Participate in supply chain development through Avalign division and external supplier selection and qualification with the new product development team.
- Participates in design reviews as required by the design control and development processes.
- Serve as GD&T expert for contract developer and specification developer activities.
- Assist project managers with design transfer planning and execution including advising on Avalign and vendor manufacturing process validations to support new product development.
- Support processes for Medical Device Reporting and Complaints for Avalign as specification developer products.
- Ensure required design documentation is retained in design history files and technical files to support regulatory submissions and audits.
- Support and maintain all regulatory filings for all Avalign Technologies design owned products whether this includes Avalign filing, supporting the customer to file, or a third party filing the regulatory submission.
- Perform corporate internal audits, either as a supporting auditor or as the lead auditor.
- Participate in external audits.
- Conduct post market surveillance for contract development and specification developer products.
- Ensure post launch product design file updates are completed following design change and post market surveillance activities.
- Write or update standard operating procedures, work instructions, or policies.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Assist in investigations of product complaints, root cause analysis, corrective action, trending and make recommendations regarding their reportability.
- Investigate and complete records related to assigned Nonconformances and CAPAs.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or other compliance issues.
What You Will Need:
- Bachelor degree or equivalent experience in an engineering or scientific field
- 5+ years of experience in quality and/or engineering role
- 2+ years of experience in medical device industry, preferred
- 2+ years of experience in quality within design control activities supporting new product development, preferred
- Experience with ISO 13485, FDA 21 CFR 820 Quality System Regulation, ISO 14971, MDR, or associated regulations.
- Ability to travel up to 25%
What You Won't Do:
- Feel stuck - we offer great opportunities to advance and learn
- Get bored - we make a high variety of products, so no day is the same
- Feel like a number - we're a close-knit bunch and always have each other's backs
Who You Are:
- A self-starter who thrives in a fast-paced environment
- A quick learner who is always ready to gain depth of knowledge in manufacturing processes
- A reliable individual who knows the importance of showing up when it counts
- Someone who accept assignments with an open, cooperative, positive and team-oriented approach
- Someone who is able to plan and execute plans across teams
- An effective communicator, both written and verbal
What You'll Enjoy:
- Competitive compensation and benefits package
- Comprehensive medical, dental, and vision insurance
- Paid vacation and 10 observed paid holidays per year
- Employer funded Basic Life and AD&D insurance
- Employer funded STD and LTD insurance
- Tuition reimbursement
- Great 401(k) with company match
- Generous employee referral bonus program
- Working for a thriving, performance-based company that values promoting from within and career advancement
- Temperature controlled environment
- Community involvement investing and giving back to the community
- Additional free resources such as travel assistance, EAP, etc.
Avalign conducts a comprehensive background, drug testing, highest level of education completion verification, and reference checks.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
- Pay Type Salary
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