What are the responsibilities and job description for the Sr. Development Quality Engineer position at TekOne IT Services Pvt. Ltd.?
Role: Sr. Development Quality Engineer
Location: St. Paul, MN - 55117
Duration: 12 Months on W2
Shift: 8:30 AM to 5 PM
Note
Seeking an experienced Development Quality Engineer to support commercial products and new product development. Key responsibilities include quality discipline support, risk management, design verification/validation, CAPA leadership, and cross-functional collaboration with R&D and regulatory teams.
Responsibilities
Bachelor's in Engineering or related field 5-8 years of medical device engineering experience Familiarity with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, MDSAP Strong organizational, problem-solving, and communication skills Ability to travel (
Preferred
Location: St. Paul, MN - 55117
Duration: 12 Months on W2
Shift: 8:30 AM to 5 PM
Note
- Hybrid role (up to 2 days off-site, some weeks 100% onsite). Local candidates only.
Seeking an experienced Development Quality Engineer to support commercial products and new product development. Key responsibilities include quality discipline support, risk management, design verification/validation, CAPA leadership, and cross-functional collaboration with R&D and regulatory teams.
Responsibilities
- Lead/support quality and business initiatives
- Conduct risk management and failure mode analyses
- Support test/inspection method development
- Oversee design validation and root-cause analysis
- Maintain Device History File (DHF) compliance
Preferred
- Cardiovascular/implantable device experience
- ASQ CQE certification preferred
- Previous Abbott experience is a plus
