Job Summary
Responsible for leading and managing quality projects throughout the quality organization. Collaborate with cross-functional teams, both internal and external to quality, and serve as a subject matter expert to ensure compliance to applicable regulations and standards; Support strategic initiatives with the goal of continually improving our global quality system as well as emergency support when unexpected challenges arise that meet your area of expertise; Plays a vital role in bridging the gap between conceptual design and practical manufacturing, contributing to the efficient and cost-effective production of high-quality products.
Job Description
MAJOR RESPONSIBILITIES:
- Lead project initiatives throughout the quality organization by collaborating with cross-functional teams. Present project deliverables to the lead team as well as communicate/train affected groups on procedural or process changes.
- Identify, lead and drive opportunities to improve the Quality Management System through increased efficiency or more robust compliance to applicable regulations.
- Leverages their understanding of the QMS to lead root cause activities as well as planning the corrective or preventative actions for critical quality concerns. Ensure actions are completed in a timely fashion with appropriate resources and supporting evidence is properly documented.
- Evaluate Cost of Quality metrics to identify cost savings opportunities. Propose projects to the lead team and execute on the implementation of approved projects.
- Manage and provide process guidance for manufacturing or corporate functions, ensuring process management is consistently applied across all corporate divisions, manufacturing sites and groups.
- Proficiency in identifying, assessing, and managing risks associated with product and/or process development projects. Apply industry-standard risk management tools and techniques (e.g., FMEA, fault tree analysis) to identify and mitigate potential risks. Complete necessary documentation related to risk management activities, including risk assessment, risk mitigation strategies, and risk control implementation.
- Own and maintain the Management Review program in alignment with ICH Q10, corporate quality standards, and site procedures.
- Coordinate collection and analysis of PQS performance data, including deviations, CAPAs, complaints, recalls, audit findings, validation status, change controls, quality metrics, and regulatory commitments.
- Facilitate periodic management review meetings with site leadership, ensuring appropriate agenda content, participation, and documented outcomes.
- Prepare management review reports and dashboards that identify trends, emerging risks, opportunities for improvement, and quality system effectiveness.
- Support inspection readiness by maintaining complete and defensible management review records and demonstrating executive oversight of the PQS.
- Ensure escalation of significant quality, compliance, and business risks to site and corporate leadership as appropriate.
Support inspection readiness and regulatory compliance activities across the organization.
MINIMUM JOB REQUIREMENTS:
Education:
- Bachelor's degree in mechanical engineering, biomedical engineering, electrical engineering, software engineering, or related science.
Certification / Licensure:
Work Experience:
- At least 7 years of experience in pharmaceutical manufacturing / some medical device engineering and/or quality assurance preferred.
Knowledge / Skills / Abilities:
- Position requires travel up to 30% of the time for business purposes (domestic and international).
- Demonstrated leadership abilities, including:
- Lead project teams by providing structure and delegating tasks in accordance with the skills of each team member
- Promote an engaging atmosphere within the group that helps foster open dialogue and is inclusive to all
- Independently manage projects to ensure deadlines are met and any delays are communicated/mitigated proactively
- Demonstrated Critical Thinking and Problem Solving abilities, including:
- Collaborating with cross-functional teams and internal customers as a key contributor and/or project manager, driving solutions and producing results for major projects such as QMS Improvements, Cost Savings opportunities, Process alignments, software launches/improvements; ensuring inputs and stakeholder needs are met
- Managing and engaging on multiple projects with competing needs and resource requirements
- Change management and leadership experience associated with process and QMS enhancements
- Improving organizational efficiencies by solving challenging and ambiguous problems with system and process solutions
- Sound judgment, ability to quickly evaluate information to make decisions while mitigating risk to the business. Capable of maintaining a sense of calm during crisis management to identify and present unique solutions.
- Exposure to statistical techniques and data collection methods to aid decision making based on data
- Good understanding of auditor expectations, able to properly document actions taken and support them through objective evidence. Able to identify compliance gaps and set forth actions to correct deficient areas.
- Demonstrated Communication and Interpersonal abilities, including:
- Communicating project status and complex subject matter to directors, vice presidents and executive members, to provide insight into the current state of the business or project, and as required, inspire the envisioned end state
- Understanding of when written or verbal communication is required and ability to tailor the information to a variety of audiences (quality, division, individual contributor, management etc.)
- Through PowerPoint or other presentation mediums, able to confidently present to both small and large groups of varying audiences
- Demonstrate the capability to transfer technical knowledge to team members through formal training sessions, one-on-one interactions, and hands-on practical experiences
PREFERRED JOB REQUIREMENTS:
Work Experience:
- At least 10 years of experience in pharmaceutical/medical device engineering and/or quality assurance.
Knowledge / Skills / Abilities:
- Strong knowledge of ICH Q10, FDA cGMP regulations (21 CFR Parts 210/211), EU GMP, and inspection expectations.
- Experience managing or supporting Quality Systems such as CAPA, Deviations, Change Control, Complaints, Audits, and Management Review.
- Demonstrated ability to analyze complex quality data, identify trends, and communicate risks to senior management.
- Experience managing disconnected data sources.
- Experience preparing and presenting inspection-ready documentation.
Experience supporting regulatory inspections and responding to health authority observations
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:
$116,000.00 - $174,000.00 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 roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.
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.
