Quality Specialist I (Inspection Coordinator)

About the Position

With a passion for life, join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Responsibilities

• Perform all Quality functions in compliance with Quality Management System (QMS) according to 21CFR820, ISO 9001:2015, and ISO 13485:2016.
• Conduct internal audits of the facility to ensure compliance with regulatory requirements under the guidance of the Head of Quality Systems and Compliance.
• Train new Quality employees and facilitate the onboarding process.
• Participate in third-party audits (FDA, ISO, other notified bodies) of the Quality System and assist with providing responses to any observations made during those audits.
• Assist management with ongoing Quality improvement initiatives. Track or trend Quality System metrics.
• Determine the source of Quality problems, make recommendations for improvements, and assist with corrective and preventative actions.
• Lead inspection establishments. Lead establishment of inspections within the ERP tool from approved inspection plans.
• Assist in quality documentation as related to New Equipment Request and changes.
• May assist in equipment qualification and validation.
• Assist in monthly presentation and defect trending of product quality performance to management as related to inspection.
• May be required to perform other duties as assigned or as needed.

Requirements

• Requires a Bachelor’s degree with 3+ years of experience in Quality within an FDA regulated environment.
• OR Requires a Master’s degree in Quality or any closely related field with 1+ year of experience in Quality within an FDA regulated environment.
• OR An equivalent combination of education and experience sufficient to successfully perform the essential duties.
• Strong knowledge of medical device regulatory requirements, including FDA 21CFR 820, ISO 9001:2015, ISO 13485:2016, etc. Medical device experience highly preferred.
• Audit training preferred.
• Fundamentals of technical writing.
• Stay abreast of current applicable Quality and Regulatory standards, guidance documents, and industry working groups.

We Offer

• Competitive salary range: $75,000-$94,000/annually + 8% STIP for 2027.
• Comprehensive benefits package including Health, Dental, and Vision insurance benefits, 401k plan with company match, Paid Time Off, Wellness initiative & Health Assistance Resources, Life Insurance, Short and Long Term Disability Benefits, Health and Dependent Care Flexible Spending Accounts, Commuter Benefits, Parental and Caregiver Leave, and Tuition Reimbursement.

About the Company

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status, or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.