Quality Engineer II

About the role

This is an exciting opportunity for a Quality Engineer II to join an orthopaedic medical device startup. This role is ideal for an experienced quality engineer who thrives in a dynamic, fast-growing manufacturing environment and is energized by taking ownership of quality activities while continuing to develop technical and leadership capabilities. The Quality Engineer II will partner with Manufacturing Engineering, R&D, Process Development, Purchasing, and Quality to embed quality into new and expanding production processes and support continuous improvement across the site. The ideal candidate is a hands-on quality engineer who works independently on assigned responsibilities, applies lean quality principles, and leads practical problem-solving on the manufacturing floor. This position is positioned between an entry-level Quality Engineer I and a Senior Quality Engineer, with responsibility for independently leading defined projects and quality activities while escalating complex or high-risk matters as appropriate. In all actions, this person shall demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

Responsibilities

• Independently own and execute assigned manufacturing quality objectives related to product performance, process control, compliance, and scalability in a fast-paced production environment.
• Provide hands-on quality support for key manufacturing processes, including sterile packaging and sterilization activities, helping ensure processes remain robust, compliant, and scalable.
• Lead investigations and resolution of manufacturing and product quality events, including nonconformances, process issues, material discrepancies, and customer complaints, and develop effective corrective and preventive actions with appropriate cross-functional support.
• Lead defined cross-functional quality and continuous improvement projects, using practical problem-solving and risk-based decision-making to improve manufacturing performance and compliance.
• Partner with Manufacturing Engineering, Process Development, R&D, Purchasing, and Quality to integrate quality requirements into new and expanding manufacturing lines, process changes, and improvement activities.
• Monitor supplier and incoming material quality performance, support supplier corrective actions, and partner with Receiving Inspection and Purchasing to address recurring quality or documentation issues.
• Apply working knowledge of inspection methods, engineering drawings and specifications, measurement tools, sampling plans, and nonconforming material controls to support sound quality decisions.
• Provide technical guidance to less experienced team members and inspection personnel within assigned areas, while escalating complex, systemic, or high-risk issues to senior quality leadership.
• Maintain clear, accurate, and timely quality records and ensure ongoing compliance with company policies, procedures, and applicable regulatory requirements.

Supervisory responsibilities

This position has no direct supervisory responsibilities. The role may provide technical guidance, training support, and day-to-day quality direction to less experienced team members or inspection personnel within assigned areas.

Location

US - Maple Plain

Qualifications

Minimum qualifications

• Bachelor's degree plus a minimum of 2 years of related work experience, or an equivalent combination of education and work experience
• Experience independently leading investigations, improvement activities, or corrective action projects
• Self-starter with demonstrated ability to manage assigned responsibilities with limited supervision and appropriately escalate complex issues
• Ability to multitask, prioritize, and meet deadlines with strong attention to detail
• Experience in the medical device industry or another regulated manufacturing environment
• Working knowledge of inspection methods, engineering drawings and specifications, measurement tools, sampling plans, nonconforming material processes, and quality documentation requirements
• Good written and oral communication skills
• Highly organized, accountable, and capable of working effectively across functions

Preferred qualifications

• Four-year engineering degree
• Experience supporting multiple quality functions in a manufacturing environment
• Demonstrated success leading cross-functional improvement or corrective action projects
• Experience with receiving inspection, incoming quality control, supplier quality, or inspection of purchased components, materials, packaging, labeling, or finished goods in a regulated environment
• Experience supporting sterile packaging, sterilization, process validation, or manufacturing process controls

Other requirements

Ability to lift up to 20 pounds