Senior Quality Engineer

Resonetics; Stony Hill (CT); On-site; USD 78,000 - 124,000; Full time

Job summary

Resonetics is seeking a Sr. Quality Engineer to join its Quality Assurance team in the US.

The role focuses on implementing and maintaining the QMS for medical device development, ensuring compliance with regulatory requirements and design controls, risk management, and post-market activities. The individual will lead quality activities across design, development, manufacture, and release, with responsibility for CAPA, change control, audits, and DHF/Device Master Records, reporting to the

Qualifications

• 5+ years of experience in a Quality Engineering role.
• Bachelor's degree or equivalent experience.
• Lean/Six Sigma experience.
• Demonstrated technical writing and communication skills.
• Strong attention to detail, organization, and verbal and written communication skills.
• Ability to interact with client companies in a professional manner and lead verification/validation activities.
• Organized and able to self-manage project tasks.
• Proficiency in Word, Excel, and PowerPoint.
• Ability to work under pressure, manage multiple projects, and meet deadlines.
• Ability to read and understand regulations, standards, and procedures.
• Experience with analytical instrument calibration preferred.

Responsibilities

• Responsible for assuring product quality, safety and effectiveness and conduct failure investigations of customer complaints.
• Ensure project teams follow QMS and regulatory standards throughout development.
• Collaborate with development engineers to update Design Controls documentation.
• Author protocols or support qualification/validation in design control deliverables.
• Perform risk assessments and implement corrective actions (CAPA).
• Lead and mentor on DHF/Device Master Record documentation and planning.
• Interact with customers and suppliers to ensure two-way information flow; conduct supplier audits as needed.
• Maintain product/process specifications, standards, and QMS documentation.
• Manage document control and ensure compliance across all processes.
• Provide statistically valid sampling plans and design of experiments support.
• Support training programs and maintain training records.

Skills

Lean Six Sigma

Technical writing

Communication

Attention to detail

Regulatory knowledge

Project management

Client interaction

Quality Engineering

Education

Bachelor's degree or equivalent experience

Tools

Word

Excel

PowerPoint

Job description

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.

The Sr. Quality Engineer is a key contributing member of the Quality Assurance team, working to implement and maintain the Quality Management System (QMS) to ensure that the activities of the company are performed in compliance with the QMS and applicable regulatory requirements. The individual also serves as a key member of product development teams to perform activities related to design, development, manufacture, and release of medical devices, including, but not limited to, design controls, validation (design, process, and/or software), risk management, design verification, and post-market activities. This person also works to identify deficiencies in quality system and device performance and recommend and implement corrective and preventive actions. This role reports to the Director of Quality Assurance and Regulatory Affairs.

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

• Responsible for assuring product quality, safety and effectiveness, and conduct failure investigations of customer complaints, as required.
• Ensure project teams are utilizing Resonetics Quality Systems and appropriate regulations and industry standards throughout the product development process.
• Collaborate with the development engineering team(s) to create and/or update documentation to support Design Controls.
• Author protocols or provides support in performing qualification validation protocols in support of design control deliverables.
• Conduct risk assessments of the design to determine ability to function as intended. Responsible for completion of risk analysis and mitigating actions.
• Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and supplier audits, product release, document control, design control process and design history files (DHF), device master records, etc.
• As a lead Quality Engineer on projects, directly contribute and/or provide guidance to others to establish appropriate Design History File / Device Master Record documentation and provide detailed planning for clinical, pilot production and scale-up builds.
• Interact with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required.
• Help create and implement and maintain product/process specifications, standards, and procedures to support QMS implementation and documentation. This involves writing and revising documents as necessary.
• Maintain QMS to ensure full compliance to all quality and regulatory requirements.
• Manage the Document Control process and ensure all steps of this process are performed.
• Provide statistically valid sampling plans when required.
• Work closely with engineering in understanding, developing and executing statistically designed experiments.
• Manage Training program, including maintenance of training records and monitoring training compliance.
• Procure and maintain external standards.
• Develop incoming, in-process, and final inspection and quality plans.
• Maintain and/or support maintenance of the Non-Conforming Material and Corrective and Preventive Action System, including NCMR (disposition, review, and approval), CAPA (initiation, review, verification, and effectiveness check), Complaint Handling (handling, investigation, and reporting) to ensure timeliness of actions and tracking metrics to support management review.
• Collaborate with all internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs.
• Support Equipment Calibration and Maintenance per the applicable procedures. Maintain accurate calibration records in accordance with internal requirements.
• Maintains detailed documentation throughout all phases of research and development, often leading documentation of user needs, product requirement and risk / test planning and execution activities.
• Assist in Incoming and Final Acceptance Activities by ensuring that proper documentation is maintained and preparing metrics as appropriate.
• Assist in the preparation of Management Review presentations and maintain accurate records of such.
• Works closely with all team members in onboarding and assessment of new suppliers and oversees supplier quality program (supplier files, approved supplier list; supplier audits, supplier performance metrics, etc.).
• Ensures that all work satisfies the requirements of the company's Quality Manual. Continually looks for improvement and compliance improvement opportunities.
• Complete projects in a timely manner and consistent with company objectives.
• Mentor junior engineers on quality system requirements.
• Any other duties as assigned.

Required Qualifications

• 5+ years of experience in a Quality Engineering role.
• Bachelor's degree or equivalent experience
• Lean/Six Sigma experience.
• Demonstrated technical writing and communication skills.

• Strong attention to detail, organization, and verbal and written communication skills.

• Ability to interact with client companies in a professional manner. Demonstrated ability to lead product verification & validation activities.

• Organized and able to self-manage project tasks.

• Proficiency in use of Word, Excel, and PowerPoint.

• Ability to work under pressure, handle multiple projects, and meet aggressive deadlines.

• Ability to read and understand regulations, standards, and procedures.

• Experiences with analytical instrument calibration preferred.

Preferred Qualifications

• Able to work in an office environment

Compensation

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $78,000-$124,000.

“For temp, temp-to-hire, and regular full-time positions, our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.”