Manager, Quality Assurance

Client: ResMed
Position Title: Manager Quality Assurance
Hiring Manager: Brittney Nickolas Global Head of Quality Fulfillment Network
Engagement Type: 12-Month Contract
Location: Atlanta GA (Fully Onsite)

ResMed is seeking a Manager Quality Assurance to oversee quality operations across multiple U.S. fulfillment sites. This is a newly created role to backfill leadership capacity while the hiring manager transitions 40% of her time to a strategic project. This is a leadership-level high-impact role supporting a regulated medical device/pharmaceutical environment. While this is structured as a 12-month contract there is potential for conversion if business needs and performance align (not guaranteed and not positioned as contract-to-hire).

• Oversee multi-site Quality Assurance operations

• Lead quality teams across active and pre-launch sites

• Ensure compliance with regulatory standards and quality systems

• Support fulfillment network quality performance

• Partner cross-functionally with HR and senior leadership

Vendors should strictly qualify candidates against the following:

• Oracle ERP experience (Required)

  • Client uses Oracle (not SAP)

• Experience working within a regulated environment

• Knowledge and practical experience with:

  • ISO 13485

  • ISO 9001

• Medical device or pharmaceutical industry experience strongly preferred

• Other regulated industries will be considered but are less desirable

• Due to contract nature candidate must require minimal ramp-up

• Location: Atlanta region

• Schedule: Fully onsite (not hybrid)

• Hours:

  • Monday Friday

  • Start time between 8:00 9:00 AM

  • 40 50 hours/week

  • Overtime: As needed

This role requires visible onsite leadership presence.

Goal: 3 interviews total

Round 1 (45 minutes):

• Brittney Nickolas (Hiring Manager)

• HR (joint interview)

Round 2 (45 minutes):

• Rafael Perez

• Jose Loza

Round 3 (45 minutes):

• David Gammell (Hiring Manager s Supervisor)

A 4th round is possible but not expected.

• ASAP

As a reminder:

• Quality over quantity

• Submission cap will apply

• Candidates must be pre-screened

• Vendors must confirm:

  • Oracle experience

  • ISO 13485 / ISO 9001 exposure

  • Regulated industry background

  • Onsite availability

  • Compensation alignment

Resumes will be reviewed by Suna before submission to the hiring manager.

The strongest candidates will demonstrate:

• Multi-site QA leadership experience

• Direct involvement with ISO audits and compliance

• Medical device or pharma background

• Experience standing up or supporting new facility launches

• Strong executive communication skills

• Ability to operate independently in a contract capacity

• New role created due to leadership bandwidth constraints

• Strategic project reducing manager availability

• Need for immediate operational stability and regulatory compliance oversight

• Indianapolis site upcoming forward-looking quality infrastructure support required

^{Quality Associate Manager/Manager Americas Fulfillment Network}

^{We are seeking an accomplished and forward-thinking Quality Manager to lead quality operations across our Americas Fulfillment Network. This role is pivotal in ensuring the implementation maintenance and continuous improvement of a robust Quality Management System (QMS) in a multi-site (Moreno Valley Atlanta and Indianapolis) regulated environment.}

^{Reporting into the global Quality function the successful candidate will serve as a strategic partner to Operations Transportation Global Trade Regulatory and Corporate Quality teams fostering a culture of excellence compliance and continuous improvement. This leader will be instrumental in ensuring operational alignment with ISO 13485 EU MDR and other global regulatory requirements.}

^{Key Responsibilities}

^{Leadership & Culture}

• ^{Led cross-functional alignment between Operations Transportation Regulatory and Quality teams to maintain compliance with ISO 13485 and across multiple fulfillment sites.}

• ^{Influenced senior leadership and cross-regional stakeholders by delivering clear quality performance insights risk trends and strategic recommendations.}

• ^{Partnered with 3PL providers and internal supply chain groups to standardize quality workflows improving service levels while reducing compliance gaps.}

• ^{Championed a quality culture across multi-site operations by driving expectations coaching leaders and embedding best practices in day-to-day processes.}

• ^{Managed stakeholder priorities in a complex environment ensuring timely investigation and resolution of systemic issues affecting delivery cost and compliance.}

^{Quality Systems & Compliance}

• ^{Developed and executed a multi-site Quality strategy aligning global QMS standards with regional operational requirements.}

• ^{Assessed fulfillment and logistics processes to identify gaps leading to multi-year roadmaps that improved audit readiness reduced defects and enhanced operational efficiency.}

• ^{Translated business objectives into quality initiatives ensuring resources were deployed effectively to support growth cost reduction and compliance.}

• ^{Modernized QMS elements through process simplification digital transformation and automation initiatives.}

• ^{Served as a strategic thought partner to Operations and Supply Chain leaders enabling data-driven decision-making and risk prioritization.}

^{Operational Excellence & Innovation}

• ^{Strong understanding of fulfillment distribution center operations logistics and transportation workflows within a regulated industry.}

• ^{Prioritize and allocate Quality resources to support business objectives related to delivery cost and compliance.}

• ^{Lead or facilitate process improvement/standardization initiatives across teams with varying levels of process discipline.}

• ^{Demonstrated ability to modernize and streamline quality processes through innovative solutions automation or digital tools.}

• ^{Deliver regular quality performance insights risk assessments and strategic updates to senior leadership}

^{Analytics Automation & AI}

• ^{Experience with AI-driven or predictive models to identify quality risks and optimize resource allocation across distribution centers.}

• ^{Enabled AI or automated tools to streamline QMS documentation automate complaint/NC triage or enhance investigation quality.}

• ^{Leveraged advanced analytics and AI-driven insights to identify root-cause trends optimize workflows and improve decision-making accuracy resulting in measurable gains in quality speed and operational efficiency.}

• ^{Introduced automated solutions that reduced manual touchpoints and improved process standardization in quality operations.}

^{Key Qualifications and Experience}

• ^{Bachelor s degree in Engineering Science Operations or related technical discipline.}

• ^{Minimum of 7 years years of experience managing or leading quality professionals within a multi-site or matrixed Fulfillment environment.}

• ^{Demonstrated success implementing and sustaining ISO 13485 or equivalent QMS frameworks.}

• ^{Hands-on leadership managing nonconformances CAPA on-hold inventory investigations and structured problem-solving (A3 8D DMAIC).}

• ^{Experience preparing for and leading internal external and regulatory audits across multi-site operations.}

• ^{Ability to drive change influence cross-functional stakeholders and prioritize in a complex environment.}

• ^{Excellent written and verbal communication skills; able to clearly present to senior leadership.}

^{Preferred Attributes}

• ^{Experience working in global or multi-regional organizations.}

• ^{Lean/Six Sigma certification or equivalent continuous improvement training.}

• ^{Ability to influence remote and cross-regional teams.}

• ^{Experience deploying digital forms automated workflows predictive analytics or advanced reporting for quality operations.}

• ^{Proven capability to simplify complex processes and lead digital transformation initiatives in regulated settings.}

^{Key Competencies}

• ^{Strategic thinker with a hands-on execution mindset}

• ^{Collaborative leadership style with strong interpersonal skills}

• ^{Highly organized with a strong attention to detail}

• ^{Passion for continuous improvement and operational excellence}

• ^{Resilient adaptable and solution-oriented}

^{Work Environment}

• ^{Multi-site 3PL operations quality oversight in (Moreno Valley Atlanta and Indianapolis).}

^{Additional Information}

• ^{At ResMed all employees participate in a bonus plan with the percentage dependent on position within the organization.}

• ^{Competitive benefits package.}

• ^{Access to a referral bonus and ResMed s preferred shareholding program.}

• ^{Internal career opportunities within an international fast-paced and rapidly growing company.}