Quality Engineer II

Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger This Quality Engineer role will work closely with both our internal and external partners to support the quality side. The individual working in this position will be supporting the implementation and maintenance of Resonetics’s Quality Systems which are used to help identify quality related issues and report quality trends in order to support the broader organizational goals. The ideal candidate will have strong attention to detail, analytical skills and ability to dive into data to support our strong material quality.

 

Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you. 

Responsibilities

• Work with customers on customer complaints (Provide them with Containment action, Root cause analysis and short / long term Corrective and Preventive actions).
• Perform training for manufacturing / Quality associates to work instructions and procedures
• Work with customer service and sales on initiating / closing returns.
• Help customers with Supplied Data Agreement requests
• Analyze and disposition Non-Conformance Reports.
• Responsible for contacting customers with any deviation from specification.
• Identification of adverse quality trends or conditions.
• Initiate corrective and preventive actions
• Monitor and track Data collection and Analysis.
• Support engineering with process validations (IQ, OQ, PQ).
• Work with Engineering to complete PPAP documentation (PFMEA, Control Plan, Flow Chart and Part Submission Warrant).
• Create, review and update Procedures and Work Instructions.
• Participate in internal and supplier audits as needed.
• Initiate Engineering Change requests to implement any change in documentation.
• Develop and implement various quality practices designed to track performance indices.
• Publish performance indices at regular intervals.
• Self-starter and the ability to work with minimal supervision.
• Support QC Final Inspection Review of ITMS, COC, Testing as needed.
• Perform additional tasks/jobs as assigned by the Manager.

Required Qualifications

• BS Degree in related field or 5+ years of relatable work experience.
• Strong computer skills with proficiency in MS PowerPoint, Excel, Word and Minitab or other equivalent statistical analysis software.
• Have the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Preferred Qualifications

• CQE or a CQA Certification is a plus.
• Work within an ISO 13485 regulated environment
• Ability to design and develop quality inspection tooling

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Compensation

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $68,000 – $81,000/year.