Sr. Quality Engineer

Join to apply for the Sr. Quality Engineer role at Actalent
.

The Senior Quality Engineer is a top-level Quality Assurance Engineer position responsible for ensuring product quality. This role involves independently completing validation and qualification activities while ensuring customer quality needs are met through cross-departmental collaboration. The position will frequently interface with customers to complete new product and process validations, address product quality issues, and maintain customer relationships.

• Plan and conduct analysis, design, testing, and integration to assure product or component quality.
• Perform engineering reviews of design and production documentation for compliance with requirements, including vendor and supplier quality manuals and company quality records.
• Apply statistical process control (SPC) or other appropriate methods to analyze data and evaluate current processes and changes, determining corrective actions if needed.
• Perform product and process validation and verification activities; generate and review related plans and reports in line with company policies and procedures.
• Develop and maintain Measurement System Analysis for new and existing products.
• Collaborate with process, production, and manufacturing engineering in the disposition of non‑conforming material, identifying the root cause, and implementing corrective and preventive actions.
• Develop new approaches to solve problems identified during quality assurance activities, prioritizing, communicating, and resolving quality issues using appropriate quality engineering practices.
• Represent the organization as a primary contact for specific projects and initiatives; communicate with internal and external customers and vendors at various levels.
• Prepare and present technical and program information to team members and management.
• Direct and collaborate with QA Technicians, Support Specialists, and other cross‑functional team members engaged in quality assurance activities.
• Maintain thorough knowledge of government and industry quality assurance codes and standards.
• Review customer complaints, SCARs, and other quality metrics, completing requested investigation and documentation in a timely manner.
• Work with suppliers in assisting with qualification and audits as needed.
• Exercise considerable latitude in determining deliverables of assignments, with limited oversight from management.
• Interview, hire, and train QA team members; plan, assign, and direct work to meet departmental objectives; appraise and document performance; reward and discipline team members; address and resolve team member complaints and problems.
• Manage mid‑sized projects or processes that span outside of the quality function.
• Perform other duties as assigned.

• Minimum of four years of experience with an advanced degree, or six years in the medical device industry with a bachelor's degree, or ten years in a related field.
• Bachelor's degree in engineering or a related field or equivalent experience; an advanced degree is preferred.
• Experience in quality engineering, CAPA, and nonconformance management.
• Proficiency in manufacturing software, spreadsheet software, Minitab or other statistical process control software, and Microsoft Office products such as Excel, Word, PowerPoint, and Project.
• Ability to use Solid Works or other CAD software.
• Auditor's training or experience with auditing.
• Working knowledge of design controls and Quality System Regulations.

• Prefer ASQ, CQE certification.
• Strong interpersonal, personal, and communication skills.
• Eager to learn and good in execution.

This is a Contract to Hire position based out of St Paul, MN.

Pay range: $50.00 – $60.00 per hour.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace…