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Prin Compliance/Audit Spec
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Prin Compliance/Audit Spec : Medtronic
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| Job Number |
MT_73060 |
| Employee Type |
Full Time |
| Company Name |
Medtronic |
| Location |
Minneapolis
Minnesota
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| Salary (year) |
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| Experience |
6 to 9 Years |
| Industry |
Medical-Device |
| Job Type |
Quality-Assurance |
| Required Degree |
Bachelors Degree |
| Relocation |
Not Required |
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| Description |
Division - Corporate Quality
Business - Medtronic Operations
Position Description
This position will be part of the Corporate Quality Audit organization and will work closely with the Audit Council, Quality Council, Corporate Legal, and key stakeholders across the business units and geographies This position will drive improvement opportunities across Medtronic in support of the initiative for One Medtronic:
Position Responsibilites
Plan, conduct and follow-up on Corporate quality internal audits. These include but are not limited to: oversight audits of business unit audit functions, audits of key processes across the company, directed audits determined by management, and first party audits of certain corporate entities.
Define the audit scope and objectives for discussion with auditees' management. Identify the audit team, facilitate the audit planning and preparation, including coaching of guest auditors and subject matter experts.
Provide quality system leadership and project management during the audit. Leverage interviewing, facilitation, negotiation, and effective communication skills throughout the audit life cycle.
Coach auditees on the development of corrective actions when necessary. Report on audit outcome to Management.
Provide consulting services across Medtronic in aspects of compliance critical to Medtronic’s overall success. Coach the organization towards increased compliance to all applicable standards and regulations.
Participate in the continuous improvement of the internal audit process and methods through the Audit Council projects and within Corporate Audit. This may include defining new audit approaches to emerging compliance areas, developing departmental work instructions, and other aspects of running a compliant audit department.
Own the projects to update Corporate Policies when needed, working to solicit input across the business units and geographies, presenting the case for change, and presenting to the governance committee for policy implementation.
Develop and lead department initiatives that support increased efficiency, quality and cost effectiveness for the entire department to ensure best industry standards and approaches
Basic Qualifications
Bachelors Degree
5+ years experience in quality audit (Medical device, Pharmaceutical, Clinical, biologics, Regulatory Agency Inspections)
7+ years experience in pharmaceutical industry or medical device industry
Demonstrated excellent written and oral communications with the ability to interface with all functions in the organization.
Excellent interpersonal, facilitation, consensus building, conflict resolution and organizational skills.
Ability to work effectively in teams as a team member.
Ability to leverage and influence networks and stakeholders
Advanced presentation skills
Excel at project planning and project management
Familiar with key aspects of compliance management
Strong business acumen
Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships
Excellent Proficiency in Word, Excel, PowerPoint, Outlook
Desired/Preferred Qualifications
Third party/FDA/ISO experience preferred
Experience with clinical regulations in medical device and pharmaceutical industry
Experience in auditing of sales and marketing organization practices and aspects of business conduct / code of conduct
Auditor Certification
Quality System experience in Pharmaceutical industry and Medical Device
Masters Degree.
Physical Job Requirements
Ability to travel up to 25% of the time
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| Requirements |
Exempt/Non-Exempt - Exempt
Travel Percentage - 20 - 30%
Relocation - Relocation eligibility to be determined
Preferred Qualification
Third party/FDA/ISO experience preferred
Experience with clinical regulations in medical device and pharmaceutical industry
Experience in auditing of sales and marketing organization practices and aspects of business conduct / code of conduct
Auditor Certification
Quality System experience in Pharmaceutical industry and Medical Device
Masters Degree.
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