Skip to main contentA logo with &quat;the muse&quat; in dark blue text.
Kforce

Quality Engineering Manager-Medical Device

Carlsbad, CA

Description

Kforce's client in Carlsbad, CA, a growing and established Innovative Medical Device Technology client is seeking a Quality Assurance Engineering Manager. We are working directly with the Hiring Manager on this exclusive search assignment. The company offers a competitive compensation package including base salary, annual bonus and stock/RSU's. This position is hybrid/remote.Summary:The Quality Assurance Engineering Manager will be accountable for ensuring the company's medical device products and future products are designed to meet all regulatory compliance requirements. This leader will report to the NPD Director of Quality Assurance, and will be responsible for the implementation, oversight and maintenance of the Design Controls, Design Assurance and Product Risk Management processes.Responsibilities:

Want more jobs like this?

Get Software Engineering jobs in Carlsbad, CA delivered to your inbox every week.

By signing up, you agree to our Terms of Service & Privacy Policy.
  • Oversee that the Design History Files in accordance with FDA regulations and standards
  • Manage a small team of R&D Design Quality Engineers
  • Oversee and support the sustaining part of the Product development lifecycle (PLC) in addition to handling product launches
  • Ensure the Device Master Records are developed and maintain in accordance with FDA regulations including all product process specifications and Hardware and software specifications, quality assurance procedures, packaging and labeling specifications and installation, maintenance and servicing procedures and methods
  • Develop and maintain design validation and design verification processes and procedures
  • Interface with research and development, manufacturing, quality, outside consultants and vendors to ensure compliance with internal and external policies and procedures, Quality System regulations and FDA/ISO regulations
  • Maintain supplier qualification, auditing, and surveillance per the QMS
  • Will be involved with the hardware electronic aspects of the products including the electronic components within the embedded medical devices and base stations

Requirements

  • Bachelor's degree or MS degree in Mechanical Engineering, Electrical Engineering, or a scientific/technical field such as Biomedical or Biotechnology or similar field
  • At least 7-10+ years of experience in the medical device industry primarily in NPD design quality engineering area
  • At least 3+ years of experience managing a team of quality engineers within a R&D Design Team
  • Strong experience with Design Controls, Design Assurance and Rick Management processes
  • Experience with collaborating and auditing of the Design History Files (DHF) is preferred.
  • A good understanding of regulatory aspects of the design process in order to push the R&D team through that process.
  • Experience having been part of an initial launch of a new medical device would be ideal
  • Track record of bringing medical devices from concept to production as well as providing guidance for the design controls and Risk management
  • Experience with drafting documentation including FMEA, Risk management files, etc.
  • Expertise in ISO 14971 application of Risk Management to Medical Devices
  • Understanding of ISO 13485 principles
  • Experience with electro-mechanical medical devices is preferred
  • Strong communication, facilitation, planning, and problem-solving skills
  • Strong influencing and negotiation skills
  • Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands
Nice to haves but not required:
  • Certified Lead Auditor
  • Other ASQ or AAMI certification
  • Experience with electromechanical systems and medical devices such as smart implants, pacemakers, artificial hearts, infusion pumps, diagnostic equipment, wireless embedded sensor devices or other similar technologies are plusses but not required
  • Advanced education on related areas
  • Experience with electrical safety standards (IEC 60601)
  • Experience working in smaller companies

The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.

We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.

Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.

This job is not eligible for bonuses, incentives or commissions.

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Kforce is a solutions firm that builds and manages expert teams in technology and finance & accounting. We deliver on our client's objectives by combining a global knowledge force with flexible delivery and an unmatched drive for excellence. Kforce not only serves as a trusted partner to our customers, providing next level insights and powerful results, but also offers many consultants comprehensive benefits including medical, dental, 401(K), life insurance and disability.

Client-provided location(s): Carlsbad, CA, USA
Job ID: Kforce-2070491-WQG
Employment Type: Other

This job is no longer available.

Search all jobs