Website Resonetics
Resonetics
Company : Resonetics
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 position will focus on Quality system compliance and Process development in the contract manufacturing of medical products. Active participant who can manage multiple and dynamically changing projects on time, while influencing change and compliance to Quality System requirements. Position requires skills in advanced Quality Engineering techniques including; Problem solving using Six Sigma methodology, Process Validations, Process Development and optimization, Gage R&R, reducing dependence on inspection, ISO 13485 and/or 21CFR820 compliance.
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 and lead cross functional teams utilizing the Product Development Process to ensure robust systems and controls are in place to produce defect free product while meeting business objectives and customer expectations.
- Influence change and ensure understanding and compliance to 21CFR820, ISO 13485 and the Product Development process Drive and participate in Continuous improvement and Process validation activities using DOE's, FMEA's, Quality Plans, Gage R&R and other Quality tools
- Work through unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on facts
- Review and approve protocols, validation documents, investigations and procedure
- Provides support by conducting investigations and assisting in data and information collection as required for quality events Interfaces as a subject matter expert with the FDA and other government agencies during site inspections.
- Responsible for the development of process and quality procedures.
- Implement Continuous improvement methodology and metrics in cell(s) to improve business metrics
- Customer liaison for all quality related issues.
- Mentor and train other engineers/technicians in quality methodologies and regulatory requirements.
- Support Equipment Calibration and Maintenance per the applicable procedures. Maintain accurate calibration records in accordance with internal requirements
- Proactively develop improvement ideas based on experienced assessment of departmental and company performance Represent Quality in project team meetings and on assigned projects
Required Qualifications:
- 7+ years experience in a Quality Engineering role for a medical device manufacturer and/or start-up company
- Experience working in a Manufacturing environment
- Demonstrated technical writing and communication skills
- Ability to drive projects with strong attention to detail
- Working knowledge of Statistical software and/or Minitab
- Bachelor's degree or equivalent experience
Preferred Qualifications:
- CQE and/or Six Sigma Green or Black belt
- ASQ certification is a plus
- Medical Device experience is a strong plus
- BS degree; Physics, Optics, Mechanical, Chemical, Plastics Engineering preferred
- Cardiovascular experience a plus
- Demonstrated expertise in one or more of the following: ISO 13485, 21 CFR 820, Lean Manufacturing, Six Sigma
- Experience with analytical instrument calibration preferred.
Physical Demands:
- 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 $78,000.00 to $(phone number removed).
Resonetics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time