Quality Compliance Project Lead (CAPA/Change Order/Quality Systems)

Hours: 8:00am-5:00 PM

Location:

Candidates local to the Maple Grove MN or St Paul MN area- Could potentially be a Hybrid role; however, if converted, it will be 100 percent onsite.

Duration: This is a 6-month contract with potential to extend or convert highly likely

Job Description:

• The Global Regulatory Services (GRS) Quality Compliance Project Lead is responsible for supporting the RA procedure harmonization and related maintenance activities post harmonization. Regulatory processes have been harmonized across 6 medical device business units.
• This position will require strong project management skills to drive meetings and business unit process alignment.
• This person will report to the Global Regulatory Operations – Quality & Compliance Senior Manager. Support GRS owned CAPA activities related to RA procedural changes.
• These activities include: managing GRS CAPA tracker, quality review for verification, lead CAPA correction and corrective action delegated activities and tasks.
• They will work with the cross-business unit RA compliance teams to update procedures, obtain cross functional review, route documents through the change order process and revise training audiences as necessary.
• This person will get experience structuring procedures, work instructions and guidance documents within the client Quality Systems.

Responsible for:

• Lead procedural updates and emerging regulation implementation working with cross BU/ cross functional teams
• Review and approval of CAPAs with attention to detail, review of completeness, accuracy, effectivity and timeliness
• Drive change order activities, supplemental training materials and related implementation activities
• Execute CAPA Review board/Management Review forums
• Review and follow document quality system structure
• Develop, redline, and compile feedback on GRS owned procedure, work instructions, forms, and templates
• Lead team meetings and document meeting minutes
• Develop and implement process related training material
• Facilitate procedure implementation
• Identify continuous improvement and collaboration opportunities

TOP 5 Desired qualifications and experience:

• Procedural Writing
• CAPA Expertise
• Project management skills – organize and lead meetings for procedural development
• 5 years experience in a regulated industry
• Familiarity with Regulatory Affairs departmental responsibilities and processes

Desired Qualifications

• Bachelor’s Degree
• Quality Systems experience desired
• Technical writing skills
• Strong communication skills (written and verbal)
• Proven success managing multiple projects and priorities
• Attention to detail
• Proficient in Microsoft Word, Visio, and PowerPoint
• Windchill experience (not Required, but a Plus)

Job Type: Contract

Pay: $87.00 - $88.00 per hour

Expected hours: 40 per week

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• change order: 5 years (Preferred)
• Quality Assurance background: 5 years (Preferred)
• Review and approval of CAPA: 5 years (Preferred)
• Project management: 5 years (Preferred)
• Pharma or medical device or biotech or healthcare industry: 5 years (Preferred)

Ability to Commute:

• Saint Paul, MN 55117 (Required)

Work Location: In person

Salary : $87 - $88