Sr. Quality Engineer

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

3 days ago Be among the first 25 applicants.

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 Arden Hills, MN.

The pay range for this position is $50.00 - $60.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical,…