Quality Specialist I (Inspection Coordinator)

Getinge; Fraser (MI); On-site; USD 75,000 - 94,000; Full time

Benefits offered by this job

Health Insurance

401k with company match

Paid Time Off

Tuition Reimbursement

Job summary

Getinge in Fraser, MI is seeking a Quality Specialist I (Inspection) to support day-to-day Quality operations in the QMS. The role involves internal audits, training, and coordinating inspections within ERP using approved inspection plans.

Responsibilities include supporting quality improvements, tracking metrics, and assisting with regulatory readiness for FDA/ISO audits. A strong background in FDA-regulated quality is required and on-site with some remote days is expected.

Qualifications

• Must have strong communication skills both oral and written.
• Ability to organize and prioritize daily duties.
• Must be a team player across organization.
• Problem solving and decisive decision making.
• Maintain focus on short- and long-term goals.
• Bachelor's degree with 3+ years in FDA-regulated quality.

Responsibilities

• Perform quality functions in compliance with QMS per 21CFR820, ISO 9001:2015, ISO 13485:2016.
• Conduct internal facility audits for regulatory compliance.
• Train new Quality staff and onboard processes.
• Assist with third-party audits (FDA, ISO, other bodies).
• Support quality improvement initiatives and track QMS metrics.
• Identify root causes and support corrective and preventive actions.
• Lead inspections in ERP from approved inspection plans.
• Assist in quality documentation for New Equipment Requests.
• May assist in equipment qualification and validation.
• Present monthly defect trends to management.

Skills

Communication

Team player

Problem solving

Time management

Decision making

Education

Bachelor's degree in Quality

Master's degree in Quality

Equivalent education/experience

Job description

Select how often (in days) to receive an alert:

Quality Specialist I (Inspection Coordinator)

Date: Sep 14, 2026

Location:
Fraser, MI, US

Remote Work: 1-2 days at home (site based)

Salary Range: $75,000-$94,000/annually + 8% STIP for 2027

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.
• 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

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
• 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.