Sr. Compliance Specialist

Primary Talent Partners has a 2-year contract opening as a Sr. Compliance Specialist with a Medical Device client located in either Mounds View, MN or Miami Lakes, FL. Pay range for this role is $35 to $45 per hour based on experience.

Job Summary:

We are seeking a meticulous and experienced Sr. Compliance Specialist to join our team. The ideal candidate will have prior experience with Corrective and Preventive Actions (CAPAs) in the Medical Device industry. The role involves overseeing compliance policies, procedures, and practices, ensuring alignment with legal and ethical standards. This position requires a strong background in process engineering, specifically Green/Black Belt work, and familiarity with regulatory requirements in the Medical Device industry.

Responsibilities:

• Develop, implement, and administer compliance policies and procedures
• Provide compliance advice and investigate complaints, ensuring deficiencies are corrected
• Develop and deliver employee communication and training programs on compliance and CAPA processes
• Analyze metrics and audit functional compliance programs
• Provide oversight for the development and maintenance of quality programs, ensuring compliance with internal and external standards
• Interpret policies, regulations, and internal guidelines to ensure compliance
• Collaborate with operating entities to enforce requirements and meet regulations
• Lead audit and inspection preparation and resolution of findings
• Prepare reports and documentation, including Corrective and Preventive Actions (CAPAs), for stakeholders
• Coordinate legal requests in support of government investigations or litigations
• Maintain and modify quality assurance programs and policies

Qualifications:

• Bachelor’s degree in relevant field
• Minimum 5 years of experience in compliance or quality assurance, preferably in the Medical Device industry
• Certification in Six Sigma, DFSS, Lean Green Belt, or Black Belt preferred
• PMI Certified Project Management Professional (PMP) preferred
• Prior experience as a CAPA Owner or CAPA Specialist highly desirable
• Strong understanding of regulatory requirements in the Medical Device industry
• Excellent communication and interpersonal skills
• Ability to work independently and collaboratively in a dynamic environment

Additional Information:

• This is a specialist-level position requiring autonomy and advanced knowledge in the field.
• Remote work candidates will be considered, but preference is given to those able to work on-site in Mounds View, MN or Miami Lakes, FL.
• Core hours are Tuesdays and Thursdays in-office, with flexibility for hybrid/remote work on Mondays, Wednesdays, and Fridays.

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
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