National Product Safety Manager

Pediatric Home Service is a friendly and professional leader in home health care with a singular passion for and commitment to taking care of the child. As a leader in home health care, we help kids achieve their best lives at home and in their communities while providing our employees a fun and rewarding place to work.

• Position: National Product Safety Manager

• Location: Roseville, MN

• Hours: Monday-Friday, 8a-5p

The Product Safety Manager is responsible for leading, managing and executing the PHS process for product safety concerns. This includes, but is not limited to, identifying corrective actions, responding to product recalls/safety notices, providing recommendations and preparing employee training. The successful candidate will be able to identify and implement product safety best-practices in order to drive regional alignment and improve processes. This individual will have the opportunity to partner cross-functionally to understand and address customer product concerns and conduct research to provide findings to support PHS legal and compliance teams.

Essential Functions

Lead and maintain the process for product safety concerns

• Indirect leadership across cross-functional, regional teams to assess potential product safety issues and take appropriate corrective action.

• Routinely make decisions regarding technical and risk tradeoffs, priorities, resource utilization and quality.

• Develop and issue responses to product recalls and other safety notices as needed.

• Drive PHS performance on Product Safety using appropriate tools / techniques to monitor progress, identify and quantify variance, and perform required corrective actions.

• Provide recommendations regarding the corrective actions as needed.

• Identify and execute on opportunities for continuous improvement in the product safety concern process.

• Coordination with regulatory and accreditation bodies on responses to product safety issues

Manage process for establishing and approving product related communications

• Develop, review, and/or approve applicable supplemental product safety information before their release to patients.

• Develop, review, and/or approve applicable supplemental product safety information in conjunctions with Payor relations before their release to Payors.

• Support development and review of customer communications related to quality or safety concerns.

• Effectively communicate recommendations and deliver oral presentations to address product safety.

• Communication to regulatory and accrediting bodies regarding Product Safety issues and activities.

Assist PHS attorneys in litigation

• Obtain necessary product information and assist counsel to prepare appropriate responses to discovery requests as needed. Give depositions, court testimony and prepare affidavits as needed.

Represent product safety in the new product development process

• Participate in new product assessment, stage gate reviews, product assessment reviews and FMEAs as needed to support the addition of products into PHS formulary and release to patients.

• Provide guidance on product safety questions raised by Clinical or CS related to new product requests.

Cascade safety practices through employee training and interactions

• Embed product safety knowledge throughout the organization, including training PHS associates on a regular basis, responding to ad hoc internal inquires and coaching on product safety.

Education and/or Experience

• Bachelors degree in engineering or related field safety field required

• Minimum 5 years' experience in engineering, quality, product compliance or risk management responsibilities required

• Masters degree in business, engineering, or related field preferred

• Project Management Professional Certification (PMP)

• Experience completing FMEAs or other RPN analyses

• Project management experience

• Experience with medical product safety and FDA protocols

• Experience in DME, Hospice, or Home Health Care

Benefits:

• Competitive pay

• Paid time off (and paid holidays)

• Health, vision and dental insurance

• Short & long-term disability & life insurance

• 401K plan

• Professional development opportunities

• Tuition reimbursement

Interested candidates should apply online; please include cover letter and resume. Please include cover letter & resume along with salary requirements in your application.

We look forward to learning more about you & the skills you can bring to Pediatric Home Service

Pediatric Home Service is an equal opportunity employer; we are committed to affirmative action and equal employment opportunities for all regardless of protected veteran status, race, color, creed, religion, national origin, sex, sexual orientation or identity, disability, age, marital status, familial status, membership or activity in a local human rights commission, or status with regard to public assistance.