Sr. Quality Systems Specialist - Mounds View, United States - Redbock - an NES Fircroft company

Description

Sr. Quality Systems Specialist (6 month contract // REMOTE, team based in Mounds View, MN):

Travel 10% domestic and internationally

W2 ONLY****

Top 3 Skills:

1. Experience with response to audit findings, corrections, and corrective actions
2. Experience with oversight of small projects, ensuring timely completion of deliverables
3. Experience with eQMS systems, ideally Agile, and Audit documentation systems, ideally TrackWise.

Duties:

• Provide continuous and rigorous assessment of quality system to assure compliance with Medtronic internal policies in general and specific to quality system processes, FDA part regulations (Design Controls, specifically Design Changes), ISO 13485, Medical Device Requirements, and governmental regulations.
• Participates in Quality System process activity across multiple sites including quality system projects and initiatives.
• Participate in, and own CAPA management activities, including corrective actions and effectivity strategies.
• Conduct root cause investigations of Quality System compliance issues; complete data analysis on investigation findings.
• Support the development and implementation of Quality System procedures.

Required Experience:

• Bachelor's degree with 4+ years of work experience in Quality, Manufacturing, or regulated industry OR Advanced degree with 2 years of work experience in Quality or regulated industry

Preferred Skills:

• Experience in a regulated environment
• Experience working with audit findings, corrections, and corrective actions
• Experience in medical device, pharmaceutical and/or a comparable regulated environment
• Influence management skills: ability to work constructively across all functions of the organization as well as external customers
• Project management skills
• Quality System documentation systems (e.g. Agile) and Audit documentation systems experience (e.g. TrackWise)
• Experience reviewing technical documentation
• Strong written and verbal communication skills
• Ability to educate people in Quality Systems and the Audit program
• Experience with quality tools and process improvement techniques
• Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
• Strong analytical and decision-making skills
• Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and client quality requirements in general and specific to CAPA.