Quality Specialist I (Inspection Coordinator)

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.

Job Overview

The primary purpose of this position is the Quality Specialist (Inspection) will provide quality support of day-to-day Quality operations of all elements related to quality inspection within the Healthmark Quality Management System (QMS).

Job Responsibilities and Essential Duties :

• 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 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 on-boarding 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 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.
• Assists 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.

Required Knowledge, Skills and Abilities:

• Communicating both orally and written with members of the organization, as well as external parties relating to Quality issues.
• Organizing and prioritizing daily duties.
• Must be a team player and able to work well with teams representing all areas of the organization.
• Problem solving and decision making – identifies and solves problem(s), acts decisively, and shows good judgement.
• Maintain appropriate focus on short-term and long-term goals.

Minimum Requirements:

• Requires a Bachelor’s degree with 3+ years of experience in Quality within FDA regulated environment.

OR

• Requires a Master’s degree in Quality or any closely related field with 1+ year of experience in Quality within 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.

Environmental/Safety/Physical Work Conditions:

• Standing and or sitting for long periods of time.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The salary range for this position is between $75,000-$94,000/annually depending on experience and 8% STIP for 2027

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About us

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.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• 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
• Tuition Reimbursement

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.