Quality Systems Engineer

SUMMARY

The Quality Engineer is an experienced quality system professional that ensures assigned quality system processes are implemented, maintained, monitored, and reported on to ensure adequacy and continuous improvement. This role will primarily focus on nonconformance and CAPA quality systems, leading and supporting investigation, root cause analysis, corrective actions, and nonconformance and CAPA processes for our North American operations including analytical testing laboratory. The ideal candidate will have a strong background in quality engineering, problem-solving skills, and a commitment to maintaining quality standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Align North American process and reporting standards to accurately document nonconformances, CAPAs, and associated corrective actions in accordance with regulatory guidelines.

• Oversee, collect and analyze quality data, and report on North America site external and internal audit observations and corrective action status.

• Collaborate with all lines of businesses as assigned to conduct investigations into product quality issues, deviations, out-of-specification events, and nonconformances, ensuring prompt and effective resolution.

• Develop training and tools to empower employees to utilize root cause analysis methodologies (6M, Fishbone, 5 Whys, etc.) to identify underlying factors contributing to nonconformances.

• Develop and implement corrective and preventive actions (CAPAs) to address identified root causes and prevent recurrence of nonconformances. Ensure that CAPAs are well-defined, executed in a timely manner, and effectively tracked to completion.

• Prepare and present reports summarizing investigation findings, root causes, corrective actions, and outcomes to management and relevant stakeholders.

• Collaborate with cross-functional teams, including Quality, Regulatory, Operations, R&D, etc .to implement process improvements based on analysis from nonconformance investigations.

• Monitor the effectiveness of implemented corrective actions, measuring key performance indicators to evaluate progress and drive continuous improvement.

• Stay up-to-date with relevant quality standards, regulatory requirements, and industry best practices related to nonconformance and CAPA processes.

• Responsible for oversight and reporting on quality data in other quality system processes, as assigned.

QUALIFICATIONS:

EDUCATION AND/OR EXPERIENCE

• Bachelor's Degree in Life Sciences or technical discipline (chemistry, biology, etc.) or related field

• Minimum four years of experience in regulated industry

• Minimum two years of direct experience in nonconformance and CAPA investigation

• Prior experience supporting and hosting regulatory inspections

CERTIFICATES, LICENSES, REGISTRATIONS

• Certified quality auditor or similar industry certification preferred

COMPETENCIES (SKILLS AND ABILITIES)

• Effectively negotiates and builds partnerships throughout multiple organizational levels of business

• Confident in resolving ambiguity, assessing and interpreting regulation, and leading ad hoc teams through compliance improvement and change

• Experience working in regulated industry (pharmaceutical, compounding, medical device, etc)

• Strong data management skills

• Detail-oriented with strong analytical skills

• Excellent verbal and written communication skills

• Ability to work independently and be self-motivated

PHYSICIAL DEMANDS/WORK ENVIRONMENT

The physical demands described here are 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.

• Pet friendly environment

• Extensive computer work

• Business travel (up to 15%)

Covetrus is an equal opportunity/affirmative action employer. It does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated with undue hardship, sex, sexual orientation, age, citizenship, marital or veteran status, or any other legally protected status.

We offer the following benefits for you to take advantage of while you are here provided you meet the eligibility requirements under each governing program:

• 401k savings & company match

• Paid time off

• Paid holidays

• Maternity leave

• Parental leave

• Military leave

• Other leaves of absence

• Health, dental, and vision benefits

• Health savings accounts

• Flexible spending accounts

• Life & disability benefits

• Identity theft protection

• Pet insurance

• Sales Positions are eligible for a Variable Incentive

• Certain positions may include eligibility for a short term incentive plan

Covetrus is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.