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Quality Assurance Specialist

2 months ago

Saint Paul, Minnesota, United States Solventum Full time
Job Title: Quality Engineer Specialist

Solventum is a leading company in the healthcare industry, and we are seeking a highly skilled Quality Engineer Specialist to join our team.

As a Quality Engineer Specialist, you will be responsible for providing quality assurance engineering support for marketed medical device products, including customer complaints, stability studies, test method validations, investigations, risk management, change management, and continuous improvement.

You will lead investigations for nonconforming materials, complaints, and supplier issues, and ensure compliance to internal Standard Operating Procedures (SOPs) and external regulations.

Additionally, you will lead Corrective and Preventive Action (CAPA), Risk Management, including Post Market Surveillance product support, Risk Reviews, and Material Review Boards.

You will represent the customer, evaluating customer complaints, and issues, samples and trends, and determining the necessary action plans.

Interacting with other domestic and international Solventum facilities and outside suppliers to ensure product quality and performance.

You will provide thorough audit support for notified bodies and government agencies, from leading audit preparation to interacting with auditors/inspectors in front room.

Other duties as assigned.

Requirements:
  • Bachelor's Degree or higher AND seven (7) years of experience in combined product, quality, engineering, and/or laboratory/technical experience in a private, public, government or military environment
  • High School Diploma/GED AND (14) years of experience in combined product, quality, engineering, and/or laboratory/technical experience in a private, public, government or military environment
  • Previous experience working in an FDA regulated device, combination, or drug environment
  • Strong demonstrated leadership ability and the ability to identify opportunities for improvement and lead teams, drive change, and get things done
  • Demonstrated proficiency in the use of statistical and quality engineering tools such as basic statistics, Gage R&R, Analysis of Variance, Failure Modes and Effects Analysis, Statistical Process Control and Capability, acceptance sampling, correlation and regression, and experimental design
  • Strong verbal and written communication skills and the ability to provide diligent, concise, and fact-based communication to Executive Management, and cross-functional peers
  • Strong decision-making, problem-solving, and continuous improvement skills with the demonstrated ability to create momentum and deliver results in a timely manner by prioritizing personal workloads, being flexible and acting with urgency
Work Environment:

Hybrid Eligible (Job Duties allow for some remote work but require travel to St. Paul at least 1 day per week)

May include up to 10% domestic/international travel

Relocation Assistance: NOT authorized

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status)

Benefits:

Solventum offers many programs to help you live your best life - both physically and financially.

To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.

The expected compensation range for this position is $119,076 - $145,537, which includes base pay plus variable incentive pay, if eligible.

This range represents a good faith estimate for this position.

The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience.

In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.).

Additional information is available at: