Sr. Quality Engineer

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 thats redefining medical device manufacturing. If youre passionate about innovation and thrive in a fast-paced environment wed love to hear from you.

• 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 companys 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.

• 5 years of experience in a Quality Engineering role.
• Bachelors degree or equivalent 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.

• Able to work in an office environment

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $78000-$124000.

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.