Sr. Quality Engineer # JN -062021-66373
Title : Sr. Quality Engineer
Location : Minnetonka, MN, 55345
Duration : 12 months contract
- Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs.
- Lead on-time completion of Quality Assurance (QA) engineering deliverables.
- Accountable for leadership, decision making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems.
- Works with and influences key stakeholders to develop and maintain QA procedures, forms, and systems. Develop and lead training for QA systems. Influence and guide other team members with product review and analysis for QA activities.
- Maintain databases and record storage for QA systems. Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
- Plan ahead for various data storage needs and communicate plans clearly to prevent potential system issues. Seeks out information independently and able mentor/lead other members of the organization on QA practices. Lead Global CAPA team with training, CAPA oversight, and CAPA deliverables.
- Proficient as lead representative for presenting QA System to internal and external auditors.
- Investigate and resolve system nonconformances and concerns (defined during internal and external audits).
- Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred) 5+ years technical experience Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies
- Detailed knowledge of FDA, GMP, and ISO 13485 Solid communication and interpersonal skills Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner Advanced computer skills, including statistical/data analysis and report writing skills
- Prior medical device experience preferred ASQ CQT, CQE, CQA certification preferred Six Sigma root cause analysis/problem solving training and experience preferred.