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Job Title: Embedded Software Engineer – Display & Guidance Systems
Location: Oak Brook, IL
Employment Type: Full-Time
Job Description
We are seeking an experienced Embedded C++ / Qt Software Engineer to support next-generation display and guidance system development for agricultural and construction equipment. This role focuses on migrating existing Android/Java-based display applications to Qt, C++, and Linux, including re-architecting middle-layer business logic and UI frameworks for high-performance embedded systems.
Key Responsibilities
- Design and develop embedded C++ applications for display and guidance systems.
- Migrate and re-architect applications from Java/Android to C++/Qt/Linux.
- Work with Systems Engineers to refine requirements and implement technical solutions.
- Develop new feature sets and enhance platform architecture.
- Support Linux device development activities.
- Perform unit testing, debugging, and performance optimization.
- Implement and support vehicle communication interfaces (CAN, LIN, Ethernet, USB, etc.).
- Address system stability, clock cycle optimization, and data latency issues.
- Collaborate with senior engineers and contribute to weekly sprint goals.
Required Skills & Qualifications
- Bachelor’s degree in Electrical Engineering, Computer Engineering, or related field.
- 4+ years of embedded software development experience.
- Strong proficiency in C++ (mandatory).
- Experience with object-oriented and multithreaded embedded systems.
- Hands-on experience with hardware-interfacing and low-level system development.
- Working knowledge of communication protocols such as CAN, LIN, RS-232/485, Ethernet, USB.
- Strong debugging, analytical, and communication skills.
Preferred / Nice-to-Have
- Experience with Qt framework.
- Java experience (legacy migration support).
- Linux embedded development.
- Experience with PostgreSQL / SQL databases.
- Version control tools such as Git.
- Automotive, agriculture, or heavy-equipment industry experience.
We are seeking an experienced Cloud Platform Engineer with deep expertise in Red Hat OpenShift and strong Linux systems engineering background. This role will be responsible for designing, building, and operating large-scale OpenShift platforms within on-premises datacenter environments.
The ideal candidate will work closely with SRE teams and Program Management to drive the successful implementation, scaling, and operationalization of enterprise-grade OpenShift infrastructure.
Key Responsibilities
1. Platform Engineering
- Design, deploy, and manage enterprise-scale Red Hat OpenShift clusters in on-prem datacenter environments.
- Architect highly available, scalable, and secure OpenShift platforms.
- Implement cluster lifecycle management (installation, upgrades, patching, scaling).
- Configure networking, storage, ingress, and security components for OpenShift.
2. Infrastructure Build & Automation
- Build and automate infrastructure in datacenter environments (compute, storage, networking).
- Integrate OpenShift with virtualization platforms (VMware/other hypervisors as applicable).
- Develop Infrastructure-as-Code (IaC) solutions using tools such as Terraform, Ansible, or similar.
- Implement CI/CD pipelines for platform deployments and updates.
3. Linux Systems Engineering
- Provide deep Linux system administration and troubleshooting support.
- Optimize OS-level configurations for performance, reliability, and security.
- Automate system configuration and compliance management.
- Diagnose and resolve complex kernel, networking, and storage issues.
4. Reliability & Operations
- Partner closely with the SRE team to establish SLOs, SLIs, monitoring, and alerting.
- Drive observability implementation (logging, metrics, tracing).
- Participate in incident management, root cause analysis (RCA), and remediation.
- Ensure platform resiliency, performance tuning, and capacity planning.
5. Program & Cross-Functional Collaboration
- Work with Program Management to drive large-scale OpenShift implementation milestones.
- Provide technical input into roadmap planning, timelines, and risk mitigation.
- Collaborate with security, networking, storage, and application teams.
- Document architecture, standards, and operational procedures.
6. Security & Compliance
- Implement RBAC, security policies, and compliance controls within OpenShift.
- Harden clusters according to enterprise security standards.
- Support vulnerability management and patch governance processes.
Required Qualifications
- 5+ years of experience in Linux systems engineering (RHEL preferred).
- 3+ years of hands-on experience with Red Hat OpenShift (OCP 4.x preferred).
- Proven experience building infrastructure in on-prem datacenter environments.
- Strong understanding of:
- Kubernetes architecture
- Networking (DNS, load balancing, firewalls, SDN)
- Storage (SAN, NAS, CSI drivers)
- Virtualization platforms (VMware, etc.)
- Experience with automation tools (Terraform, Ansible, GitOps).
- Strong troubleshooting and problem-solving skills.
Preferred Qualifications
- Red Hat certifications (RHCE, OpenShift Certification).
- Experience implementing OpenShift at enterprise scale (multi-cluster environments).
- Experience working in SRE-driven environments.
- Knowledge of DevOps/GitOps practices.
- Experience with monitoring tools (Prometheus, Grafana, ELK, etc.).
Job Title: Product Owner – Automation Framework
Location: Portland, OR
Job Type: Full-Time
Role Overview
We are seeking an experienced Product Owner – Automation Framework to lead and drive automation initiatives for Virtualized Android, Linux/QNX based In-Flight Entertainment (IFE)and infotainment platforms. This role will own the vision, roadmap, and delivery of automation frameworks supporting Qualcomm SOM based embedded systems and will work closely with cross-functional engineering teams to ensure scalable, high-quality automation solutions.
Mandatory Skills
- Automation Framework development & ownership
- Virtualized Android Environment
- Linux & QNX Operating Systems
- Qualcomm SOM / Embedded Platforms
- In-Flight Entertainment (IFE) Systems
Key Responsibilities
Product Leadership & Strategy
- Own the product vision, roadmap, and backlog for the Automation Framework supporting IFE platforms.
- Define and prioritize automation features based on business value, platform needs, and delivery timelines.
- Establish KPIs for automation coverage, stability, efficiency, and adoption across platform teams.
- Drive automation strategy for:
- Virtualized Android environments
- Linux and QNX subsystems
- Qualcomm SOM hardware platforms
- IFE integration and certification workflows
Agile & Delivery Management
- Create and maintain clear epics, features, and user stories for automation tools, APIs, and workflows.
- Refine backlog items to ensure feasibility, clarity, and engineering alignment.
- Partner with Scrum Master and Engineering Leads to enable predictable sprint-based delivery.
Stakeholder Collaboration
- Act as the primary liaison between automation engineering and cross-functional stakeholders.
- Gather and translate requirements from system verification, platform software, airline program teams, and integration labs.
- Communicate roadmap, progress, dependencies, and risks with clarity and consistency.
Required Qualifications
- 7–10 years of experience in Automation Framework / Embedded / Platform Software Product Ownership
- Strong understanding of Virtualized Android, Linux/QNX, and Qualcomm embedded platforms
- Experience working within Agile/Scrum automation engineering teams
- Strong stakeholder management, documentation, and communication skills
- Prior exposure to IFE, avionics, mobility, o
This role assists with supplier assessments, documentation review, audits, and issue resolution to ensure compliance with FDA regulations, ISO standards, and internal quality system requirements.
The position partners cross functionally while developing foundational expertise in supplier quality and regulatory compliance.
Job Description MAJOR RESPONSIBILITIES Conduct supplier audits to verify compliance with ISO 9001, ISO 13485, and applicable regulatory requirements related to high-risk vendors.
Support supplier qualification, re‑qualification, and disqualification activities for moderate to high‑risk suppliers, including documentation review and approval routing.
Review and approve supplier quality records and compliance documentation in accordance with internal procedures.
Execute Supplier Corrective Action Requests (SCARs) by tracking actions, verifying evidence, and documenting effectiveness under supervision.
Assist with supplier communication related to quality requirements, documentation requests, and corrective actions to Medline’s internal business partners and external suppliers Provide technical guidance and training to suppliers on quality standards and best practices.
Support containment activities and investigations related to supplier nonconformances Utilize root cause analysis and risk management tools to prevent recurrence of issues.
Maintain accurate and timely records of supplier audits, performance reviews, nonconformances, and corrective actions.
Prepare routine reports, dashboards, and summaries for supplier quality performance and compliance tracking.
MINIMUM JOB REQUIREMENTS Education Bachelor’s degree in Engineering, Biology, Quality Management, or related field.
Certification / Licensure Work Experience 3–5 years in supplier quality, manufacturing quality, or similar role.
Knowledge / Skills / Abilities Knowledge of ISO standards, FDA regulations (if applicable), statistical process control (SPC), and quality tools (FMEA, PPAP, APQP).
Strong communication, problem-solving, and negotiation skills.
Medical Device or drug experience Travel up to 25% (domestic and/or international) PREFERRED JOB REQUIREMENTS Education Certification / Licensure ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional.
Six Sigma Green Belt or higher.
Work Experience Supplier quality auditing Audit hosting experience Knowledge / Skills / Abilities DISCLAIMER All duties and requirements are subject to possible modification to reasonably accommodate individuals with disabilities.
This position description in no way states or implies that these are the only duties to be performed by an employee occupying this position.
Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor(s)/manager(s).
This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship.
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position: $92,000.00
- $138,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.
This role is bonus and/or incentive eligible.
Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
For a more comprehensive list of our benefits please click here .
For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career.
We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.
Explore our Belonging page here .
Medline Industries, LP is an equal opportunity employer.
Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Job Summary
We are seeking a detail-oriented Quality & Regulatory Specialist to support compliance, quality management, and regulatory activities. This role ensures adherence to international regulations and standards, supports product registrations, and maintains the company’s Quality Management System (QMS). This position requires strong knowledge of medical device regulations (e.g., FDA, EU MDR, ISO 13485) and excellent cross-functional collaboration.
Essential Duties and Responsibilities
- Regulatory Affairs
- Lead preparation, submission, and maintenance of global regulatory filings (FDA 510(k)/PMA, EU MDR Health Canada and other international registrations).
- Serve as primary contact with regulatory authorities, notified bodies, and certification agencies.
- Interpret evolving regulatory requirements and communicate strategic implications to leadership.
- Provide regulatory input on new product development, product changes, labeling, and marketing materials.
- Monitor regulatory changes and advise internal teams on impact to product development and market access.
- Quality Management System (QMS)
- Maintain and improve the QMS in compliance with ISO 13485, 21 CFR Part 820, and applicable standards.
- Support internal and external audits, inspections, and corrective actions.
- Ensure document control, training, and change management processes are properly implemented.
- Product Lifecycle Support
- Partner with R&D, manufacturing, and clinical teams to ensure design control, risk management, and post-market surveillance compliance.
- Review and approve quality/regulatory aspects of labeling, promotional materials, and product changes.
- Support vigilance reporting, complaint handling, and CAPA activities.
- Cross-Functional Collaboration
- Provide regulatory and quality guidance during new product development.
- Liaise with regulatory authorities, notified bodies, and certification agencies.
- Train employees on regulatory and quality compliance topics.
- Perform other duties as assigned by manager or supervisor
Experience & Education Requirements
- Bachelor’s degree in engineering, life sciences, regulatory affairs, or related field or equivalent work experience in those areas.
- 5-8 years of experience in quality and/or regulatory affairs in the medical device industry.
- Strong knowledge of ISO 13485, ISO 14971, 21 CFR Part 11/820, EU MDR 2017/745.
- Experience with regulatory submissions (FDA, EU, or other international markets).
- Excellent analytical, organizational, and communication skills.
Preferred Skills & Abilities
- Medical device industry experience
- Medical Device regulation requirements knowledge, as applicable to responsibilities
- Regulatory Affairs / Quality Assurance Certification (e.g., RAC, CQE, CQA) is a plus.
Position Overview
The Transmission Planning & Interconnection Manager is responsible for leading
interconnection and transmission-related activities throughout the development and execution
of utility-scale renewable energy projects. Working under the guidance of senior
interconnection leadership, this role supports projects from early site screening through
construction and commissioning. Responsibilities include technical analysis, coordination
with utilities and system operators, oversight of interconnection studies, and support of
regulatory and compliance activities. The position serves as a primary technical interface
between internal teams, external consultants, transmission owners, and market operators.
Key Responsibilities
• Oversee interconnection activities for a portfolio of solar and battery storage projects
across multiple stages of development and construction.
• Coordinate closely with transmission owners, RTOs/ISOs, consultants, and internal
stakeholders regarding applications, studies, modeling assumptions, and technical
requirements.
• Perform and direct power flow, interconnection, and economic analyses to evaluate
site viability, system impacts, and optimal project sizing.
• Analyze transmission constraints, congestion exposure, curtailment risk, and nodal or
basis risk associated with prospective and active projects.
• Support the review, negotiation, and execution of interconnection agreements,
including technical schedules and exhibits.
• Guide the development and review of preliminary interconnection designs, including
single-line diagrams and protection concepts.
• Develop and manage interconnection schedules aligned with overall project
development plans and EPC timelines.
• Monitor the engineering, procurement, and construction of interconnection facilities
executed by utilities or third-party contractors, including leading coordination calls as
needed.
• Track market rule changes, ISO stakeholder processes, and transmission planning
updates, and communicate relevant impacts to project teams and leadership.• Support generator registration activities with utilities, RTOs/ISOs, and applicable
regulatory bodies.
• Assist with compliance efforts related to ISO, NERC, FERC, and other regional
reliability or market requirements.
Qualifications & Experience
• Bachelor’s degree in Electrical Engineering, Power Systems Engineering, Computer
Engineering, or a related discipline.
• Minimum of 5 years of experience in transmission planning, interconnection, power
markets, or related roles within the electric power industry.
• At least 3 years of hands-on experience with power flow, production cost modeling,
or transmission analysis tools such as PowerWorld, PSS®E, PLEXOS, TARA, or
similar platforms.
• Demonstrated project management capability; professional certification (e.g., PMP) is
a plus.
• Proven ability to work independently, manage multiple priorities, and drive complex
workstreams to completion.
• Strong written and verbal communication skills, with the ability to present technical
information clearly to both technical and non-technical audiences.
• Highly organized with strong analytical, problem-solving, and attention-to-detail
skills.
• Experience with interconnection processes in ERCOT and MISO markets is strongly
preferred.
• Prior responsibility for managing interconnection applications and studies is highly
desirable.
• Programming or automation experience, particularly using Python, is a plus.
• Ability to advocate for and protect organizational interests in technical and
commercial discussions.
Job Title: Applications Engineer
Location: Charlotte, NC
Job Type: Direct Hire – Fulltime
Summary
The Applications Engineer will support CNC machining operations through advanced programming, process optimization, and technical application development using Siemens NX. The ideal candidate will have strong hands – on experience with CNC machines and verification
systems such as Vericut, ensuring accuracy, efficiency, and high-quality mold production.
Qualification Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and ability required. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential functions. The individual will need to work 6:30 am – 4:00pm.
Key Responsibilities
• Develop, modify, and optimize CNC programs using Siemens NX (CAM) for tire mold components including sidewalls, tread rings, segments, plates, and related tooling.
• Support both New Mold machining processes.
• Create and validate CNC toolpaths, machining strategies, and post-processing solutions within NX CAM.
• Customize and configure NX environments, including templates, libraries, and best practices to improve efficiency.
• Troubleshoot design and manufacturing issues related to CAD/CAM workflows and propose effective solutions.
• Utilize Vericut or similar verification software to simulate and validate CNC programs to prevent collisions and reduce machine downtime.
• Collaborate with CNC machinists, programmers, and engineering teams to improve manufacturability and production flow.
• Analyze machining processes to reduce cycle times and improve tool life.
• Provide technical troubleshooting support for machining issues on the shop floor.
• Assist in fixture design, tooling selection, and process standardization.
• Maintain accurate documentation of programs, revisions, and engineering changes.
• Support ERP and planning systems as related to machining workflows.
• Ensure compliance with quality and safety standards (ISO 9001 preferred; ISO 45001 knowledge a plus).
• Stay current with new Siemens NX releases and participate in continuous improvement initiative to enhance design automation, standardization, and manufacturing efficiency.
Required Qualifications
• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or related field (or equivalent work experience).
• 3–5 years of experience in CNC programming and machining within a manufacturing environment.
• Advanced proficiency in Siemens NX (CAM).
• Strong understanding of multi-axis CNC machines (3-axis, 4-axis, and 5-axis preferred).
• Experience working with tire molds or similar complex tooling.
• Strong understanding of G-code and machining strategies.
• Ability to read and interpret engineering drawings and GD&T.
• Hands-on troubleshooting experience on CNC equipment.
Preferred Qualifications
• Experience using Vericut for CNC program simulation and verification.
• Experience in tire mold manufacturing or precision tooling industry.
• Familiarity with ERP systems and digital manufacturing integration.
• Knowledge of process improvement methodologies.
• Experience supporting ISO-certified manufacturing environments.
Essential Functions
• Develop, test, and maintain NX Open programs, macros, and automation scripts to support tire mold design and engineering workflows.
• Write, modify, and optimize G-code programs for CNC machining of tire molds..
• Automate repetitive design and machining tasks within Siemens NX to improve efficiency and accuracy.
• Troubleshoot and resolve issues with NX automation tools and G-code programs
• Maintain documentation for all software tools, scripts, and machining instructions.
• Ensure all coding and machining processes comply with internal quality standards and ISO 9001/45001 requirements.
• Provide technical support, training, and guidance to team members on the use of automated tools and machining programs.
Physical Demands
• Prolonged periods of sitting at a desk and working on a computer.
Work Environment
• Professional office environment.
• Climate-controlled workspace.
• Prolonged periods of sitting at a desk and working on a computer.
• Regular use of standard office equipment (computer, phone, printer, etc.).
• Standard business hours in an office setting, occasional overtime work based on job complexity and schedule.
• Low to moderate noise levels.
• Minimal exposure to physical hazards.
Our client is seeking a skilled Information Security & Compliance Specialist to design, implement, and maintain IT security frameworks with a focus on ISO 27001 standards. The ideal candidate will bring a depth of experience in compliance, security frameworks, and IT best practices, working closely with Managed Service Providers (MSPs) and internal stakeholders to ensure a robust security posture.
**This is a contract opportunity located in South San Francisco**
Key Responsibilities:
- Develop and implement IT security frameworks in alignment with ISO 27001 information security standards.
- Conduct internal audits of current IT procedures to identify vulnerabilities and recommend enhancements following best practices in security management.
- Collaborate with IT Managed Service Providers (MSPs) to support and execute compliance roadmaps and ensure timely achievement of security goals.
- Establish and enforce user account setup, access policies, and Single Sign-On (SSO) integrations.
- Utilize security tools such as Crowdstrike, JumpCloud, and SSO applications to manage system security, access, and endpoint protection.
- Maintain documentation related to compliance, audits, and security controls.
- Keep up to date with industry trends and regulatory changes impacting information security and compliance.
Qualifications:
- Proven experience implementing IT frameworks that comply with ISO 27001 or similar information security standards.
- Demonstrated expertise in IT compliance, security frameworks, and internal/external audit processes.
- Experience working with MSPs and coordinating third-party IT/security initiatives.
- Hands-on familiarity with Crowdstrike, JumpCloud, SSO implementations, and policy management for user security.
- Strong communication and project management skills.
- Relevant certifications preferred (e.g., ISO 27001 Lead Implementer/Auditor, CISA, CISSP).
Benefits available to contract/temporary professionals, include medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit for more information. Robert Half will consider qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.
Head of Operations and Manufacturing Ripple Medical | California (Hybrid or Remote) | Full-Time
ABOUT RIPPLE MEDICAL
Ripple Medical is a health tech company on a mission to revolutionize hypertension management with our cuffless blood pressure wearable. Once cleared by FDA, our product will enable patients to easily and accurately monitor blood pressure at home, empowering them and their providers with actionable data to improve outcomes. We're a collaborative, mission-driven team of 33 working in a medical device regulatory environment to bring this technology to the millions of patients who can benefit.
POSITION SUMMARY
The Head of Operations and Manufacturing will own the end-to-end operational infrastructure required to bring Ripple's FDA-regulated cuffless blood pressure monitor to market and scale production. This is a hands-on leadership role for someone who thrives building from zero to one in a regulated environment: selecting contract manufacturers, standing up supply chains compliant with FDA 21 CFR Part 820, establishing ISO 13485-certified quality management systems, and preparing for direct-to-patient fulfillment.
As a company preparing for 510(k) submission and commercial launch, this role is critical to ensuring we can reliably manufacture and deliver a high-quality, FDA-cleared medical device at scale. The ideal candidate brings deep experience in medical device manufacturing (particularly wearable or electro-optical devices), understands regulated hardware supply chains and design transfer, and can roll up their sleeves while building the team and processes for long-term growth.
This position reports directly to the CEO with high visibility to the leadership team and Board of Directors.
KEY RESPONSIBILITIES
Manufacturing & Production
- Lead selection and onboarding of contract manufacturing partners with Class II medical device experience, including RFQ, quality audits, contract negotiation, and ongoing management.
- Own design transfer and manufacturing transfer, working with engineering on DFM principles, Device Master Record (DMR) requirements, and production readiness.
- Establish production planning, forecasting, and capacity management for V&V builds, pilot production, and volume manufacturing.
- Drive continuous improvement in yield, quality, and cost while maintaining FDA and ISO compliance.
- Oversee pilot runs and scale-up, including process validation (IQ/OQ/PQ) and manufacturing controls.
Supply Chain & Procurement
- Build and manage the end-to-end supply chain, including component sourcing, supplier qualification, and inventory management per FDA purchasing controls.
- Develop supplier relationships and negotiate terms while ensuring supply continuity, traceability, and risk mitigation.
- Implement inventory planning to balance working capital with service levels, including buffer strategies for Year 1 launch.
- Monitor and mitigate supply chain risks: component shortages, single-source dependencies, geopolitical factors, and logistics disruptions.
Quality & Regulatory Compliance
- Maintain and improve the ISO 13485-certified QMS in partnership with the quality and regulatory team, ensuring FDA 21 CFR Part 820 compliance.
- Support 510(k) submission activities related to manufacturing, including process validation documentation, DMR development, and device history records (DHR).
- Define incoming inspection, in-process controls, and final product testing consistent with the risk management file.
- Manage product certifications for a Class II device, including FDA registration, UDI compliance, and applicable international requirements.
- Lead root cause analysis and CAPA for quality issues, ensuring post-market surveillance compliance.
Fulfillment & Logistics
- Design the direct-to-patient fulfillment strategy, including 3PL selection with FDA-cleared Class II device experience.
- Establish logistics and distribution for nationwide shipping of a regulated device with chain-of-custody and traceability.
- Develop returns, replacement, and warranty processes that balance patient experience, cost, and compliance.
Team & Organizational Development
- Start as an individual contributor who executes hands-on, then build and lead the operations team through 510(k) clearance and commercial launch.
- Establish operational metrics and dashboards for manufacturing, supply chain, and quality performance.
- Partner with finance on cost modeling, COGS optimization, and operational budgeting.
- Collaborate cross-functionally with engineering, software, regulatory, and commercial teams.
QUALIFICATIONS
- 7-12 years in manufacturing, operations, or supply chain, with 3-5+ years in medical devices (Class II preferred), wearables, or regulated hardware.
- Experience managing contract manufacturers for regulated medical devices, preferably in Asia and/or domestically.
- Experience at or with CMs/EMS providers (Flex, Jabil, Celestica, Plexus, Sanmina) in Class II medical device or wearable programs is a strong plus.
- Track record of design transfer and scaling production from pilot to volume for regulated products.
- ISO 13485 and FDA 21 CFR Part 820 experience required.
- Familiarity with the 510(k) process and manufacturing documentation (process validations, DMR/DHR) strongly preferred.
- Bachelor's in Engineering, Supply Chain, Operations, Biomedical Engineering, or related field; MBA or advanced degree a plus.
- Based in California or travel up to 25%.
COMPENSATION
- Base Salary: $160,000 - $210,000 USD
- Performance Bonus: Tied to company milestones and personal objectives
- Equity: Early-stage stock option grant with meaningful ownership
- 100% Employer-Paid Healthcare: Medical, dental, and vision
- Additional Benefits: 401(k) with company match, flexible PTO
Quality Manager
We are seeking an experienced Quality Manager to build, implement, and lead the Quality Assurance function within our fragrance and liquid manufacturing operations. This is a hands-on, individual contributor role responsible for establishing robust quality systems, ensuring GMP compliance, leading ISO certification efforts, and driving continuous improvement across production and laboratory environments.
The ideal candidate has direct experience in fragrance, flavor, cosmetics, or other liquid consumables manufacturing and possesses strong scientific, analytical, and regulatory expertise.
Key Responsibilities
- Design, implement, and maintain the Quality Management System (QMS).
- Develop, revise, and control SOPs, work instructions, batch records, and quality documentation.
- Establish document control, change management, deviation management, and CAPA systems.
- Create scalable systems to support company growth and regulatory compliance.
- Ensure compliance with Good Manufacturing Practices (GMP) applicable to fragrance and liquid production.
- Lead ISO 9001 certification efforts and maintain audit readiness.
- Prepare for and manage internal and external audits.
- Oversee training programs to ensure adherence to quality standards.
- Conduct daily floor audits of compounding, filling, labeling, and packaging operations.
- Monitor raw material inspection, in-process controls, and finished goods release.
- Oversee batch record review and approval.
- Ensure laboratory testing procedures meet established specifications and validation standards.
- Maintain calibration and preventive maintenance programs for quality-critical equipment.
- Establish KPIs and quality metrics for production performance and defect reduction.
- Implement statistical tools for trend analysis and process capability evaluation.
- Develop reporting dashboards and executive-level quality summaries.
- Lead root cause analysis using structured methodologies (e.g., 5 Whys, Fishbone, FMEA).
- Drive corrective and preventive actions with measurable outcomes.
- Investigate non-conformances, deviations, and customer complaints.
- Identify systemic risks and implement preventative controls.
- Collaborate with Production, R&D, and Supply Chain to resolve quality issues.
- Lead initiatives to reduce waste, improve batch consistency, and strengthen process control.
- Prepare and present regular quality performance reports to executive leadership.
- Provide clear analysis of trends, risks, and mitigation strategies.
- Serve as the subject matter expert for all quality-related matters within the organization.
Qualifications
- 5+ years of Quality Assurance experience in fragrance, flavor, cosmetics, or liquid consumables manufacturing.
- Demonstrated experience implementing and managing GMP-compliant systems.
- Direct experience with ISO 9001 certification and audit management.
- Strong understanding of chemical formulation processes, batch manufacturing, and laboratory testing.
- Proficiency in statistical analysis, data collection systems, and quality metrics tracking.
- Experience developing SOPs, quality documentation, and structured CAPA programs.
- Strong technical writing and executive reporting skills.
- Bachelor’s degree in Chemistry, Chemical Engineering, Microbiology, or related scientific discipline preferred.
Preferred Qualifications
- Experience building or restructuring a Quality department.
- Lean, Six Sigma, or other process improvement certification.
- Experience working with ERP or Quality Management Systems (QMS).
- Familiarity with IFRA guidelines and raw material compliance documentation.
Performance Expectations
- Establish a fully structured and documented Quality Management System.
- Achieve and maintain ISO certification readiness.
- Reduce deviations, defects, and customer complaints.
- Improve process consistency and batch reliability.
- Create measurable, data-driven visibility of quality performance for leadership.