Quality Assurance Engineer
Apple & Associates Mentor, OH
- Posted: over a month ago
- $65,000 to $85,000 Yearly
- Benefits: 401k, dental, life insurance, medical, vision,
Quality Assurance Engineer
Our client, a successful and growing $30M Medical Device Company in optical and hand-held technology products sold to primary care, hospitals and retail pharmacies is searching for a Quality Assurance Engineer. The Quality Assurance Engineer will be part of the team that implements, manages, and improves the company quality system is compliance with by analyzing data, reporting trends, and providing solutions to any quality and technical issues affecting quality. In addition, the Quality Assurance Engineer will review and improve the RMA process, provide support as a Field Service Engineer, and also provide engineering support to production with respect to resolving customer issues and complaints.
Quality Engineer Essential Functions/Skills:
- Manages the nonconforming product process which includes, but is not limited to, investigating root causes, updating risk analyses, following up with suppliers, implementing dispositions, and ensuring timely closure of nonconforming product reports.
- Authors post market surveillance reports and supports management reviews.
- Owns the CAPA process to investigate root cause, propose corrective and preventive actions and verify effectiveness to ensure timely closure of reports.
- Analyzes quality KPIs such as complaints, non-conformances, CAPAs etc., report trends, and develop solutions based on trending activities as needed.
- Liaises with customers (including product users), both as support and in the field, resolving issues efficiently and accurately
- Participates in Internal compliance audits and supports External quality audits to ensure Quality System Compliance.
- Participates in risk management activities including FMEA(s), development of product Design History Files (DHF), Design History Records (DHR), and Device Master Records/Technical Files (DMR/Tech File) for product changes.
- Leads the Complaint Management by investigating and documenting reports for all complaints.
- Performs mandatory adverse event and vigilance reporting when required, to the FDA and foreign governments.
- Supports product release activities and other duties as assigned
Quality Assurance Engineer Job Requirements:
A Bachelor's degree in Engineering is required. Working knowledge of ISO 13485, CMDR, MDR, 21 CFR 820, and/or medical device industry is preferred. The Quality Assurance Engineer will liaison with multiple departments, including Customer Service, Sales, Production, and Engineering.
- Minimum of one year experience.
- Excellent written and verbal communication, and able to utilize Microsoft Outlook, Excel, Power Point, and Word effectively.
- Technical writing experience is preferred.
- Must have ability to analyze processes, suggest improvements, and implement the improvements.
- Must show appropriate judgement and logic to validate the data and improvements to the processes.
- Ability to troubleshoot problems with electrical mechanical equipment is nice to have
- Estimated travel is less than 20%, on an as-needed basis
Apple & AssociatesWhy Work Here?
This is a successful manufacturing company with locations throughout the United States.
You would work directly for our client company. Apple & Associates is an executive search firm serving the biotech and medical device manufacturing industries. Providing extensive coverage of these worldwide markets, Apple & Associates has forged a solid reputation in the industry as a highly regarded and resource-rich recruiting firm. You will not work for Apple & Associates, but full-time and permanent for the client company described here.