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Mgr I, Quality – Supplier Quality/Validation – Medina, NY

BAXTER

This is a Contract position in Lexington, KY posted November 23, 2021.

This is where you save and sustain lives At Baxter, we are deeply connected by our mission.

No matter your role at Baxter, your work makes a positive impact on people around the world.

You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home.

For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other.

This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

SUMMARY: This position is responsible for the Baxter-Medina Supplier Quality and Process Validation activities.

Supplier Quality.

The primary responsibility of this role is to establish, maintain, and continuously improve the Baxter-Medina Supplier Quality process to ensure compliance with all applicable QMS requirements, including 21 CFR Part 820 and related FDA requirements, ISO 13485 and related regulations and standards, other relevant international requirements, as well as Baxter corporate QMS requirements.

The individual works closely with Baxter Global Procurement and Supplier Quality organizations, Baxter-Medina Receiving Inspection and Operations teams and Baxter’s suppliers to ensure that: The appropriate organizational structure, resources, responsibilities and processes, policies, procedures, documents and records have been established and are maintained to meet the QMS requirements; The raw materials and components received from suppliers meet all design and QMS requirements; and The established supplier controls are effective in monitoring and maintaining the quality, safety and effectiveness of Baxter-Medina products.

Process Validation.

The primary responsibility of this role is to establish, maintain and continuously improve the Baxter-Medina Process Validation process, and to ensure compliance with all applicable QMS requirements, including 21 CFR Part 820 and related FDA requirements, ISO 13485 and related regulations and standards, other relevant international requirements, as well as Baxter corporate QMS requirements.

The individual works closely with Baxter Global Design & Development organizations and Baxter Medina Receiving Inspection and Operations teams to ensure that: The appropriate organizational structure, resources, responsibilities and processes, policies, procedures, documents, and records have been established and are maintained to meet the QMS requirements; The currently validated manufacturing processes, measurement systems, and computerized systems are appropriately monitored and remain in a validated state; and New or proposed changes to processes, measurement systems, or computerized systems are assessed, and necessary activities are identified and executed to ensure that the manufacturing processes at Baxter Medina can produce product within specification with a high degree of assurance.

ESSENTIAL FUNCTIONS: Ensures compliance with all applicable regulatory and corporate QMS requirements.

Manages direct reports (including supplier quality engineering and process validation engineering staff) and works closely with all other functions to maintain the suitability and effectiveness of the QMS.

Manage the Supplier Quality activities in the Quality organization with responsibility for results in terms of quality system and product quality.

Maintain and continuously improve the Supplier Quality program and ensure its effectiveness and compliance with applicable regulatory requirements.

Serves as subject matter expert for the Medina Supplier Quality and Process Validation systems.

Identify and manage personnel involved in continuous improvement projects with the objective of achieving quality, reliability and system improvements.

Establishes and maintains appropriate metrics and measures, including those for Supplier Performance and Process Validation, and perform data analyses in accordance with applicable procedures to identify issues and trends to initiate and execute corrective and preventive action where indicated.

Supports and participates in internal/external quality audits, including regulatory inspections, as an overall QMS subject matter expert as well as their direct areas of responsibility.

Ensures the efficiency, effectiveness and compliance of the Process Validation activities, and that new processes and/or changes to existing processes are appropriately assessed and validated prior to release.

Performs other duties as assigned.

QUALIFICATIONS, KNOWLEDGE AND SKILLS REQUIRED: Extensive knowledge of relevant FDA, Health Canada and other international regulatory QMS requirements.

Demonstrated knowledge of current regulatory interpretations of QMS requirements and current industry best practices.

Ability to multi-task effectively.

Ability to review/approve complex design documents and evaluate them for applicable application of Key Design Characteristics/Critical Quality Attributes, inspection capability, GD&T, and manufacturability.

Understand simple and complex measurement equipment and their capabilities/limitations.

Proficient in computer system use, including but not limited to Microsoft Office Suite and QMS software.

Strong analytical and problem-solving skills.

Ability to manage/supervise a team of employees.

Good communication and leadership skills.

Good interpersonal/communication/influencing/negotiation skills.

Good project management skills.

EDUCATION/EXPERIENCE REQUIRED (minimum): BS degree in science or engineering.

5 years experience in Quality, Manufacturing, Engineering or related field, in the medical products industry, which should include 1-2 years of supervisory experience.

PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee: Able to sit, stand, walk throughout the workday.

This position may also require periodic business travel car/plane (less than 10%).

WORK ENVIRONMENT: Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture.

Some of those work rules include but are not limited to: Wearing a static protective smock at all times while in the work area Working in close proximity to other employees.

Working in an environment that is temperature and humidity controlled.

IND-USOPS LI-MW1 Equal Employment Opportunity Baxter is an equal opportunity employer.

Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law EEO is the law
– Poster Supplement Pay Transparency Policy Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

035028