Engr Quality

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

Job summary

Solventum in Brookings, SD, is seeking a QMS / Facilities Quality Engineer to lead cross-functional validation activities, write IQ/OQ/DQ docs, and support facility qualification and remediation efforts.

You will partner with global sterility, production, and maintenance teams to tackle facility design and contamination issues, lead internal audits, and manage CAPAs within the QMS framework. A strong regulatory background is required.

Qualifications

• Bachelor's degree in science, engineering, or manufacturing discipline is required.
• Five or more years of experience in engineering, validations, quality, or a technical role.
• Knowledge of ISO 13485, ISO 9001, MDSAP, ANVISA, FDA QSR, and EU MDR regulations.

Responsibilities

• Lead cross functional facilities validations / qualification activities (IQ/OQ).
• Support facility requalification and contamination control efforts.
• Draft, review and approve Facility and QMS documents/procedures.
• Coordinate with project managers, global sterility, production and maintenance teams.
• Lead internal audits and audit teams; manage CAPAs.
• Act as QMS SME for plant questions and regulatory standards.

Skills

Troubleshooting

Investigation

Remedial Action

Non-conforming issue analysis

Regulatory knowledge (ISO 13485 ISO 90

Education

Bachelor's degree in science, engineering, or manufacturing discipline

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:

QMS / Facilities Quality Engineer (Solventum)

3M Health Care is now Solventum

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.

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

Your skills and experience / In order for you to succeed in this role from day one, Solventum requires

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.

Additional required qualifications

• 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.
• 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.

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

Work Authorization

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 (explicit)

Corporate policies, procedures and security standards are complied with while performing assigned duties.

Equal Opportunities

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.