5542 - Senior Quality Specialist / Quality Engineer

Description

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise
  
  

Senior Quality Specialist / Quality Engineer

Key Responsibilities:

• Maintains strong partnerships/collaboration with PFG suppliers, cross-functional resources, and GSQ project team. Facilitates communication between supplier and ICU Medical Global Supplier Quality project team and Program Manager.
• Provides input to specification changes and coordinates change orders to route and approve changes.
• Provides direct support in initiating updates and facilitating change approvals to product Bill of Materials (BOM) structures in PLM system.
• Partners with Global Procurement, R&D/engineering, and RA, as needed, to support the verification and actions required to complete and support each SKU change. Proactively initiates any required follow-up to resolve open commitments.
• Collects and tracks data related to project deliverables for assigned SKUs and suppliers and provides periodic updates to the GSQ Program Manager.
• Reviews and approves deliverables ensuring quality & compliance to applicable regulations.
• Identifies and escalates areas of risk or non-compliance to manager / leadership team
  
  

Requirements:

• Bachelor's degree and relevant GxP work experience
• 5-8 years' experience performing quality and project management activities
• Supplier Quality experience preferred (medical device related or similar – e.g., FDA regulated industry)
• Proficiency with regulations related to FDA / MHRA regulations
• Use of computerized quality management systems preferred
• Quality metrics, dashboards, analysis and improvement programs
• Proficiency in using Microsoft Office Applicaitons.
  
  

This is a hybrid role with onsite support requirements expected in Plymouth, MN or Lake Forest, IL

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

• Verista is an equal opportunity employer.
  
  

National (US) Range

$55.80—$55.80 USD

Benefits

Why Choose Verista?

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement
  
  

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For more information about our company, please visit us at Verista.com