Engr Quality

Solventum; Brookings (SD); On-site; USD 124,000 - 171,000; Full time

Job summary

Solventum is seeking a Quality Engineer In QMS / Facilities to drive cross-functional validation activities and ensure compliance with quality systems. You will author IQ/OQ documents, participate in facility design, and support requalification efforts across production areas and labs.

The role partners with project managers and global teams to resolve design or damage issues while maintaining regulatory standards.

Qualifications

• Bachelor's degree in science, engineering, or manufacturing with 5+ years in engineering, validations, quality, or technical role.
• Experience with troubleshooting, investigation, remedial action and non-conforming facility issues.
• Knowledge of ISO 13485, ISO 9001, MDSAP, ANVISA, FDA QSR (21 CFR Part 11), and EU MDR preferred.

Responsibilities

• Lead cross-functional facilities validation/qualification activities.
• Write/perform IQ/OQ documentation for new or remodeled production areas and labs.
• Support facility design development and requalification activities.
• Review/approve facility and QMS documents and procedures for compliance.
• Lead internal audits and manage CAPAs.
• Coordinate with project managers, sterility, production and maintenance teams.

Skills

Quality Assurance

Regulatory knowledge

Investigation & analysis

Education

Bachelor's degree in science/engineering/manufacturing

Job description

At Solventum, we improve lives by helping healthcare professionals do their best work. Join a team using innovation and insight to make a real impact on the future of healthcare. All roles listed are with Solventum, and we’re committed to protecting your personal information - learn more in our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/

Job Description

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You’ll Make in this Role

As a Quality Engineer In QMS / Facilities, You Will Have The Opportunity To Tap Into Your Curiosity And Collaborate With Some Of The Most Innovative And Diverse People Around The World. Here, You Will Make An Impact By

• Leading Cross Functional Facilities Validations / Qualification activities:
• Writing / Performing IQOQ documentation for new or remodeled production areas and labs
• Participate in Project facility design development process
• Supporting requalification process’ for facility related areas - such as HEPA filter through third parties
• Supporting any facility maintenance or contamination control activities: review / approval / verification
• Drafting, reviewing, owning, and approving Facility and QMS Documents/Procedures to compliance requirements.
• Working closely with project managers, global sterility assurance, production and maintenance teams to perform troubleshooting and resolve facility design or damage issues.
• Lead Internal audits and audit teams
• Create and Complete Audit reports in ComplianceQuest
• Create and Manage CAPAs associated with Internal or External audits
• Host / Participate in external audits when necessary
• Act as QMS SME for Plant questions or concerns with reference to Regulatory Standards
• Develop and Maintain Pest Management through QMS compliance regulations
• Identifies, plans, recommends, and completes quality programs involving innovative applications and extensions of existing and new technologies of major importance to division business.
• Maintains extensive network of resources (laboratory, manufacturing, engineering, sales and marketing) to facilitate completion of assignments.
• Independently performs project planning. Establishes project objectives and priorities. Maintains an awareness of quality improvement and product opportunities and is productive in evaluating ideas and making proposals.
• Documents results, observations and conclusions in approved electronic files and prepares reports to communicate results to appropriate personnel. May train, counsel, and guide technicians, technologists, operation personnel, and engineers. Functions as an effective team leader and promotes harmonious and efficient working relationships.
• The job also requires performing other duties as assigned. Percentages of time spent on job duties are estimates and may vary for each position

Qualifications

Your skills and experience / In order for you to succeed in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor's degree in science, engineering, or manufacturing discipline and (7) seven years of experience related to handling and knowledge of test equipment and/or Metrology in a private, public, government or military environment.

In addition to the above requirements, the following are also required:

• Five (5) or more years of experience in engineering, validations, quality, or other technical role.
• Troubleshooting, Investigation, Remedial Action, and Analysis of Non-Conforming Facility related issues.
• Knowledge or certification in medical device industry regulations such as ISO 13485, ISO 9001, MDSAP, ANVISA, FDA QSR (21 CFR Part 11), and EU MDR.

Additional qualifications that could help you succeed even further in this role include:

• Validation experience / knowledge
• Professional quality certifications, such as Certified Quality Auditor (CQA), Certified Medical Device Auditor (CMDA), Certified Quality Engineer (CQE), or any others through American Society for Quality (ASQ) is preferred.
• Demonstrated project leadership abilities on highly technical and complex projects.

Location: On site - Solventum Plant in Brookings, SD.

Travel: Can include up to 10% [domestic or international]

Relocation Assistance: No

You must be legally authorized to work in the destination country without the need for a work visa (e.g., H1B).

Supporting your well-being

Solventum offers many programs to help you live your best life, both physically and financially. To ensure competitive remuneration and performance, Solventum regularly compares itself with other companies of comparable size and scope Applicable to US Applicants Only: The expected compensation range for this position is $124,000 - $170,500, 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: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards

Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

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