Quality Manager

Why Join Us

Werea mid-sized medical deviceandcontract manufacturer which means you get the best of both worlds: meaningful work in a regulated environment without the layers of bureaucracyyoullfind at larger organizations.

Here your ideasdontget lost in anapproval chain. Team members are encouraged to provide feedback share suggestions and directly see the impact of their work on processes products and outcomes. What you contribute matters and you can see it come to life.

Becausewerealwaysgrowing and evolvingthere isa strong opportunity for individuals who enjoy building improving and solving problems. Ifyouresomeone who is comfortable rolling up your sleeves taking ownership and helping shape how things are doneyoullthrive here.

We dobestwith people who are curious hands-on and motivated to learn and returnyoullgain exposure across functions develop new skills quickly and have a direct role in improving how weoperate.

Position Summary:
The Quality Manager provides leadership and functional ownership of the Quality Management System (QMS) within a regulated manufacturing environment. This roleis responsible formanufacturingand qualityoperations ofClass II medical devicesandcustomer products ensuringcompliance with applicable regulatory requirements driving continuous improvement and safeguarding product quality and customer satisfaction.

This is a hands-on role requiring direct involvementin CAPA execution complaint resolution audit preparation and quality position exercises independent judgment and discretion in interpreting quality data assessing risk and determiningappropriate correctiveand preventive actions.

Duties andResponsibilities:

• Provide leadership and functional ownership of the Quality Management System (QMS) within a regulated manufacturing environment ensuring compliance with FDA ISO 13485 and other applicable regulatory requirements.

• Maintain organizational readiness for internal and external regulatory audits and ensure sustained compliance posture including representation during audits and leadership of audit response and closure activities.

• Lead the development implementation and continuous improvement of quality systems processes and standards to ensure operational effectiveness and regulatory with operations and engineering leadership to resolve complex production quality issues and implement sustainable corrective actions.

• Own and govern the end-to-end quality system for CAPA and complaints including prioritization investigation strategy root cause analysis corrective action effectiveness and closure quality data trends and systemic issues to drive risk-based decision-making and preventive actions.

• Provide oversight of supplier quality performance including escalation and corrective action nonconforming material trends and determineappropriate dispositiondecisions based on risk and business impact.

• Provide quality oversight for new product introductions and process changes to ensure compliance and risk with engineering manufacturing and leadership teams to evaluate quality risks and drive resolution strategies.

• Lead develop and support quality personnel byestablishingexpectations priorities and performance effective execution of quality system requirements across the team and promote accountability and capability team activities with organizational qualityobjectivesand continuous improvement initiatives.

MinimumQualifications:

• Bachelors degree in Engineering Quality Life Sciences or related field (or equivalent experience).

• 5 years of progressive quality experience in a regulated manufacturing environment (medicaldevicesstrongly preferred).

• Strong working knowledge of FDA 21 CFR Part 820 and/or ISO 13485 requirements.

• Direct experience leading CAPA complaint handling nonconformance and audit processes.

• Demonstrated ability to apply root cause analysis and risk-based thinking to complex quality issues.

• Proven experience working cross-functionally with engineering operations and leadership teams.

• Experienceparticipatingin or leading internal and external regulatory audits

• Ability to analyze quality trends and drive systemic improvements.

• Strong communicationskills with the ability to influence across functions.

What Sets You Apart

• You takea hands-on approach takeownership of qualitysystemsand drive issuesthroughresolution.

• You are comfortable making decisions in a regulated fast-paced manufacturing environment.

• You can balance compliance requirements with practical operational execution.

• You thrive in cross-functional environments and influence outcomes acrossteams.

• You focus on long-term system improvement not just short-term fixes.

Compensation:
Caerus Corp provides the following information about compensation for this position:

• Salary Range: $90000 $130000per year.

• Benefits:

• Health dental vision basic life and AD&D insurance

• 401(k) retirement plan with employer match

• Paid time off(Vacation and Protected paid time) and6 companydesignatedholidays

• Tuition Assistance Program

• Employee Brace Program

The salary rangeis based on several factors which will vary based on include labor marketsand in some instancesmayincludebut not limited toeducation work experiencescope and responsibilities of position andgeographic location.

Employment Eligibility / E-Verify:

Caerus Corpparticipatesin the federal E-Verify program to confirm the employment eligibility of all newly hired employees. Employment eligibility will be verified afterhirethrough completion of Form I-9 and the E-Verify process as required by law.

Equal Opportunity Employer:

Caerus Corp is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability protected veteran status or any other status protected by applicable federal state or local law.

Reasonable Accommodation
The Company is committed to providing reasonable accommodation to qualified individuals with disabilities. If you require assistance or accommodation during the application process please contact.

Caerus in BlaineMNis a developer manufacturer and marketer of innovativeClass II medical devicesmedicaldevicesand soft brands include:OrthoCorMedical Red Fox Innovations and New Options Sports.