Job Summary
Oversee and lead Quality Assurance functions for Manufacturing Quality, Sourcing Quality, and Sterility Controls. Provide enterprise-level strategic direction and operational leadership to ensure effective quality controls, compliance with applicable regulatory requirements, and alignment across manufacturing, supplier, sourcing, and sterility-related processes. Lead teams responsible for supplier quality controls, manufacturing quality systems, sterilization, process validation, pFMEA, DMR requirements, and related production and supply-chain quality controls.
Job Description
MAJOR RESPONSIBILITIES
- Oversee, lead, and set strategic direction for Manufacturing Quality, Sourcing Quality, and Sterility Controls. Lead related Corporate Quality activities in partnership with manufacturing, sourcing, supplier quality, and divisional leaders to assure adherence to US FDA, EU MDR, and other applicable requirements.
- Develop and mentor staff through on-boarding, open communication, training and development opportunities and performance management processes; build and maintain employee morale and motivation; ensure the team is appropriately staffed with required competencies.
- Lead quality activities that support manufacturing operations and sourcing processes, facilitating effective communication between Quality Assurance leaders, manufacturing teams, sourcing partners, suppliers, and divisional personnel to support business objectives and ensure quality requirements are met.
- Direct quality efforts for supplier qualification, sourcing controls, manufacturing quality activities, sterilization, process validation, pFMEA, DMR requirements, and production quality controls. Assure appropriate communication between related functions and ensure project timelines, objectives, escalation pathways, and compliance requirements are met.
- Provide leadership for Manufacturing Quality and Sterility Controls, including oversight of sterilization, process validation, pFMEA, DMR activities, and associated quality systems to ensure effective controls and compliance with applicable requirements.
- Develop training programs, approve process and procedural changes.
- Ensure proper systems are in place to facilitate a smooth and efficient process for new products and services.
- Oversee that all internal and external customers receive outstanding service from QA department.
Management Responsibility
- Lead, organize, plan, direct, staff, coordinate, and communicate across the QA management team and staff responsible for Manufacturing Quality, Sourcing Quality, and Sterility Controls to execute the business plan and operational changes needed to meet company-specific goals.
- Provide guidance and direction to subordinate leaders, including setting performance standards and monitoring performance.
MINIMUM JOB REQUIREMENTS
Education
- Typically requires a Bachelor's degree in a business-related field or related experience in medical device, OTC pharmaceutical or cosmetic manufacturing
Work Experience
- At least 15 years of QA related experience in a regulated business environment (i.e., Medical Device, OTC drugs, Cosmetics)
- At least 10 years of progressively responsible people-leadership experience, including hiring, developing, motivating, directing, and holding leaders and teams accountable for performance, organizational effectiveness, and succession planning.
- At least 5 years of senior executive-level experience, at the Vice President level or above, leading a multi-site quality organization with responsibility for cross-functional execution, organizational capability, and enterprise-level quality outcomes.
Knowledge / Skills / Abilities
- Willing to travel up to 50% of the time for business purposes (within state and out of state and international).
- Strong knowledge of Quality Assurance practices in regulated industry (Device, Pharma, Personal Care or Food).
- Leadership skills for leading an organization and coordinating resources, policies and employees.
- Experience establishing & maintaining relationships with individuals at all levels of the organization, in the business community & with vendors.
- Excellent interpersonal and negotiation skills.
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:
$309,000.00 - $464,000.00 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.