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Program Manager
Mounds View, Minnesota  |  Remote
Contract Position
It appears that you have already applied to this job.
Applied on May 21, 2022
Job Id #56131 Posted May 3, 2022


*completed 4 year degree (no exceptions)
*background check required

Responsibilities may include:

  • This position (QS PM) supports EMEA regional remediation programs: EU MDR (European Union Medical Device Regulation - (EU) 2017/745), UK MDR (United Kingdom Medical Devices Regulation - UK MDR 2002 (SI 618 as amended by EU exit regulations 2019 (SI 791) & 2020 (SI 1478), and UK MMD (United Kingdom Medicines & Medical Devices Act 2021).
  • QS PM performs OEM supplier outreach to confirm OEMs compliance and product remediation / implementation progress for EU MDR and UK MDR/MMD regulations.
  • QS PM provides program oversight. QS PM is accountable for overall program performance and customer satisfaction, with direct responsibility for daily tasks necessary for program execution but no responsibility for hire/fire decisions or people management. Program strategic decisions are generally made only after consultation with higher-level management.
  • QS PM works directly with multiple Operating Units (OUs) stakeholders, who will define OEM suppliers and products within scope for outreach. QS PM also works directly with other areas of the organization, specifically sustaining Supplier Quality and/or Supply Management stakeholders who own day-to-day OEM product continuity and OEM supplier relationships.
  • COMMUNICATION AND INFLUENCE: QS PM communicates and leads meetings with internal stakeholders and external OEM suppliers. QS PM prepares reports and provides updates to applicable stakeholders. QS PM may conduct briefings to stakeholders and/or higher-level management team.
  • ORGANIZATIONAL IMPACT: Outputs of OEM outreach provide key inputs to OUs remediation and/or implementation program strategies.
  • INNOVATION AND COMPLEXITY: Program requires careful balancing to fulfill program goals while maintaining sustaining OEM product strategies and supplier relationships. Program requires detailed information gathering, analysis and follow-up to understand OEMs current product remediation / implementation status.

REQUIRED KNOWLEDGE AND EXPERIENCE:

  • Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
  • Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization. Knowledge of or previous experience with Standards/Regulations and/or external suppliers is required for this role.
  • Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.

PREFERRED KNOWLEDGE, EXPERIENCE AND DIFFERENTIATING FACTORS:

  • Previous experience working with external suppliers, OEM preferred.
  • Working knowledge of EU MDR and UK MDR/MMD compliance requirements, direct experience preferred.

Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.

In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact hr@horizontal.com.

All applicants applying must be legally authorized to work in the country of employment.

EQUAL OPPORTUNITY EMPLOYMENT SURVEY

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You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Horizontal is proud to be an Equal Employment Opportunity/Affirmative Action Employer providing a drug-free workplace.

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