Senior Quality Engineer Job at Technical Source, Raleigh, NC

TkNKcnVwV0p0VmxOaEZINmpndndnTmtiS2c9PQ==
  • Technical Source
  • Raleigh, NC

Job Description

As a Senior Quality Engineer, you will be part of a cross-functional team that creates high-quality, regulatory compliant, innovative products that delight our customers and improve our world. The Senior Quality Engineer is engaged in all phases of product development (conceptualization, development, verification, commercialization), and will help to develop the skills and provide mentorship of other engineers within the team. You are a technical leader passionate about product development and have design quality experience within regulated industries.

Primary Accountabilities:

  • Support development of engineering / product concepts that are innovative, high-quality, cost-appropriate, and satisfy all stakeholder's (customer, manufacturing, material, agency, etc.) needs and requirements through an established area of technical specialty and mentorship of others on the global discipline team.
  • Manage or support risk management activities including risk management planning and Risk Analysis ownership activities such as FTA and DFMEA.
  • Ensure adherence to defined laws, regulations, standards, guidelines, and specifications primarily in the healthcare and life sciences industry (IEC 60601-1, 21 CFR 820, ISO 13485, ISO 14971, etc.).
  • Ensure adherence to Quality Management System (which follow ISO 9001, ISO13485, AS9100, and 21CFR820).
  • Demonstrate effective communications (teleconference, email, and in-person) through interaction with customers (internal and external) regarding project technical subject matter.
  • Demonstrate skill in the full product realization process, specifically pre-production.
  • Demonstrate the ability to work independently in multiple phases for the Product Realization Process, without direction from mentors or functional management.
  • Assist project management in the development of proposals to ensure accurate technical, staffing, budgetary, and schedule content.
  • Demonstrate desire and skill in coaching and mentoring other quality team members on technical and role-related competencies.
  • Drive continuous improvement of QMS processes through CAPA and other improvement initiatives.
  • Support the Lean culture and effectively utilizes Lean Sigma concepts and tools to identify and eliminate waste while improving processes.

Required Qualifications

  • A Bachelor's degree in Engineering
  • Five (5) years of relevant experience
  • Compliance in regulated environments, specifically healthcare and life sciences
  • Full life cycle product development with a focus on pre-production
  • Quality documentation for regulatory submissions

Additional Qualifications

  • Experience planning and guiding design verification activities
  • Strong decision making, problem solving skills
  • Experience working with Safety Agencies (such as Nationally Recognized Testing Laboratories (NRTL))
  • Intermediate cybersecurity experience, specifically planning, threat modeling, and risk management
  • Experience ensuring product compliance in aerospace industry (AS9100)
  • Experience managing product testing (ex. safety, EMC, transportation)
  • Experience performing Non-Product Software Validation

Job Tags

Contract work,

Similar Jobs

Visiting Angels of Chino

Private Duty Caregiver Job at Visiting Angels of Chino

 ...About the Role: We are seeking qualified private duty caregivers to join our team at Visiting...  ...: Assist clients with personal care, including bathing, grooming, and dressing...  ...years previous experience as a caregiver or home health aide required ~ Certification in... 

DMC Primary Care

Medical Front Desk Receptionist Job at DMC Primary Care

 ...We are seeking a high energy Front Desk Receptionist for our brand new primary care practice in...  ...environment The capability to manage time effectively while always treating patients...  ...experience is preferred This is a part-time position with approximately 24-28 hours... 

C. H. Thomas Search, LLC

Plant Manager (Manufacturing) Job at C. H. Thomas Search, LLC

 ...Initiating a search PLANT/MANUFACTURING MANAGER for a small/mid-sized and growing manufacturer (located close to Fremont, NE) who is looking for an experienced manufacturing leader to lead a mid-sized team and help to better position their product(s) and facilitate additional... 

BCI Construction INC

Experienced Carpenter Job at BCI Construction INC

 ...trim, or hardware, using carpenters hand and power tools Paint prep, cutting, and rolling of new and existing structures Demolition / Breakdown of existing structures (drywall, studs, flooring, electric, plumbing, etc.) Knowledge, Skills, and Abilities: Ability... 

M J Transport of Tampa Inc

Dump Truck Driver Job at M J Transport of Tampa Inc

Dump truck driver full time, willing to work some weekends and nights. Hauling rocks, gravel, dirt, milling, asphalt tones and more. Most have clean CDL license for two years. Prefer some experience but willing to trained. Needs to be reliable and one time to the job sites...