Sr. Quality Engineer - Quality Operations

Job title: Sr. Quality Engineer - Quality Operations

About the Role As a Sr. Quality Engineer specializing in Quality Operations at Getinge, you will oversee and improve the quality of manufacturing processes, ensure regulatory compliance, and drive continuous improvement to enhance product quality and customer satisfaction. You will play a key role in ensuring manufacturing operations meet high standards of quality, efficiency, and regulatory alignment.

What You'll Do

• Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards.
• Establish and monitor KPIs to assess manufacturing quality and identify opportunities for improvement.
• Participate/Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements.
• Develop/review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability.
• Ensure through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans.
• Support/investigate and resolve Out of Tolerance events identified during equipment/instrument calibrations.
• Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA). Track CAPA effectiveness.
• Support Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee.
• Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues.
• Facilitate risk management activities related to manufacturing processes, identifying and mitigating risks to product quality, safety, and efficacy.
• Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively.
• Lead and support continuous improvement projects to enhance manufacturing processes, reduce defects, and optimize productivity.
• Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and SPC, to drive process optimization and waste reduction.
• Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards.
• Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes.
• Provide mentorship and guidance to new Engineers/Interns within the organization.

What We're Looking For

• Bachelor’s degree in engineering, science, or other related field.
• A minimum of 7 years’ experience in Quality or Engineering.
• Experience in a medical device or pharmaceutical industry.
• Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred.
• Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR.
• Knowledgeable on Design Controls and Risk Management requirements.
• Knowledge of application & selection of Sampling Plans to support Risk-based Manufacturing Controls Plans.
• Project management and leadership experience is desirable.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
• Ability to work effectively in a cross-functional team environment.
• Ability to review and understand technical standards and their requirements for products.
• Proficiency in Microsoft Office products such as Word, Excel, or equivalent.

Nice to Have

• ASQ CQE or Six Sigma Green Belt or other applicable certifications.

Compensation & Benefits

• Salary range: $115k - $120k plus 10% annual bonus.
• Benefits include Health, Dental, and Vision insurance; 401k with company match; Paid Time Off; Wellness initiatives; Life Insurance; Short and Long Term Disability; Health and Dependent Care Flexible Spending Accounts; Parental and Caregiver Leave; Tuition Reimbursement.
• Getinge is an equal opportunity employer.