Sanford Health Quality and Regulatory Specialist - Commercialization in Sioux Falls, South Dakota

Job Title: Quality and Regulatory Specialist | Commercialization | Sioux Falls

City: Sioux Falls

State: South Dakota

Department : Commercialization

Job Schedule: Full Time

Shift: Days

Hours Per Shift: 8 hr

JOB SUMMARY

Responsible for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. Lead the development of Quality System tools, systems and training programs. Partners with subject matter experts to assist in developing test methods, equipment acquisition for new product testing, validations/qualifications, statistical analysis of data, and other documented requirements for quality objectives. Review and approve product related study protocols, data, records, and reports. Oversee production of products to ensure manufacturing and analytical testing are performed in accordance with applicable company procedures and comply with all applicable regulatory requirements. Provide final disposition for product lots. Provide QA approvals for change notices, test methods, and test equipment to assure the design and production of products are in compliance with applicable standards. Drive corrective action investigations implementation, and verification activities. Participates in new product development to identify, apply, and update quality document for compliance with standards or regulatory requirements as it pertains to product design, manufacture, and labeling. Performs audits of finished products, final inspections, returned and serviced products. Supports the filing of Sanfords regulatory filings, distribution control database, adverse event reporting, complaints, and returns. Support regulatory inspections and third part audits. Required to work with diverse populations of people from researchers and physicians to consumers.

POSITION RESPONSIBILITIES

Monitors product manufacturing and quality system processes for compliance with company and regulatory quality management. Adheres to quality management processes and practices. Analyzes patterns and identifies key areas for improvement of processes or results. Applies key aspects of continuous improvement processes and evaluates impact on quality. Develops and monitors ongoing techniques for assessing the quality of product manufacturing. Maintains current certifications in specialty and continues education when necessary. Works with quality assurance methods, tools and techniques. Assists in detailed project plans including cost, schedule, and resource requirements.

DEPARTMENT DETAILS

QUALIFICATIONS

Bachelors Degree required in STEM (Science, Technology, Engineering, and Math) field. Minimum of 3 years related work experience required working in the Medical Device industry. Thorough knowledge of applicable regulatory rules and guidelines e.g., cGMP, ICH, GCP, GLP, SOPs strongly preferred.

About Sanford Health:

At Sanford Health, we are dedicated to the work of health and healing.

Every day, we show that commitment by delivering the highest quality of care to the communities we serve.

We are leaders in health care and strive to provide patients across the region with convenient access to expert medical care, leading-edge technologies and world-class facilities.

In addition to strong clinical care, we are also committed to research, education and community growth.

We engage in medical research to not only discover innovative ways to provide care, but also cures for common diseases.

We continuously seek new ways to achieve our vision of improving the human condition here in your community, across the region and around the world.

The entire team at Sanford Health recognizes the value of healthy families and communities.

We continue to gain momentum and expand our reach. Together, we can make a positive difference now, and in the future.

Sanford is an EEO/AA Employer M/F/Disability/Vet.

If you are an individual with a disability and would like to request an accommodation for help with your online application,

please call 1-877-673-0854 or send an email to talent@sanfordhealth.org .

City: Sioux Falls

State: South Dakota

Job Function: Quality and Risk Management

Job Schedule: Full Time

Shift: Days

Req Number: req27611