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C. R. Bard, Inc.

Quality Operations Manager

C. R. Bard, Inc. - Moncks Corner, SC

Quality Operations Manager

in

Moncks Corner

South Carolina

The Quality Operations Manager is responsible for all in-process quality control functions and QA activities throughout the manufacturing process. This role is responsible for assisting in planning, organizing, coordinating, and leading projects relating to manufacturing process quality in addition to supporting the requirements of the Quality System. The Quality Operations Manager may also function as the Facility's Complaint Handling Coordinator and will be the site QA Manager delegate as needed.

Manage and effectively lead quality engineers, lab supervisors and other quality team members as deemed necessary.

Hire, train, develop, and manage exempt and non-exempt employees.

Ensure effective and meaningful development plans are in place for direct reports.

Administer the testing and controlling of raw material, in-process, and finished product quality, assuring compliance with company standards and applicable government regulations.

Coordinate / perform customer complaint investigations according to plant and corporate QA guidelines, conduct trending on customer complaints, and effectively communicate to upper management.

Coordinate and conduct routine and directed audits as needed to assure compliance with domestic and international regulations, local SOP’s and corporate standards.[i.e. QMS , QSIT, Combination Products, Regulatory requirements; Notified Bodies, etc]

Participate / lead quality improvement activities pertaining to customer complaints or adverse quality trends.

Conduct internal audits and coordinate corrective actions and closure for internal and external audits as necessary.

Perform continuous quality control evaluation and trend analysis on product quality issues, resolve quality issues and initiate corrective actions with other departments as required.

Assist with the preparation and maintenance of department budgets. Maintains comprehensive knowledge of applicable regulatory authority quality and regulatory requirements and their interpretation.

Facilitate QA/QE support for new product launches to ensure robust development, validation (IQ, OQ, PQ), rollout, and implementation. • Coordinate with Operations and Engineering in developing and implementing projects for improvement of processes / products. • Provide feedback to Operations on opportunities related to quality and/or compliance.

Draft appropriate documents to support the Quality systems. Support the document control and project management systems. • Support the vendor qualification/assessment requirements of the facility.

Make decisions on product/process quality based on evaluations.

Demonstrated ability to effectively collaborate and partner with all levels of management in corporate and division level sites while maintaining an appropriate assertive style is critical.

Strong knowledge of statistics and quality engineering / failure investigation techniques.

Effective project management, communication, and organizational skills.

Excellent interpersonal skills.

B.S. in Science or Engineering field

5 years quality, compliance and regulatory experience in the medical device industry preferred.

Combination product and/or pharmaceutical experience preferred.

• 2 years personnel management experience

While performing the duties of this job, the employee is frequently required to stand; walk; use hands or arms (to finger, handle or feel objects, tools, or controls). The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and talk or hear.

The noise level in the work environment is normally quiet to moderate.

100% of day spent indoors.

Travel 5-10% maximum (domestic and international)

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Industry Standard/Category: Manufacturing/Medical Device

ID: 2017-10857

Career Level: experienced

Division Name: Moncks Corner/BMD

Relocation: Yes

External Company Name: C.R. Bard, Inc.

External Company URL: www.crbard.com

C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.

We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.

Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.

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11 days 20 hours ago

C. R. Bard, Inc.

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Quality Operations Manager C. R. Bard, Inc. - Moncks Corner, SC, United States

   

Location: Moncks Corner, SC

Company Profile:
BARD markets its products and services worldwide to hospitals, individual health care professionals, extended care facilities, and alternate site facilities. BARD pioneered the development of single-patient-use medical products for hospital procedures; today BARD is dedicated to pursuing technological innovations that offer superior clinical benefits while helping to reduce overall costs.