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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management Systems (QMS), risk management, and compliance within regulated industries, with a strong focus on Design Controls and process optimization. Proven ability to lead cross-functional teams and establish effective stakeholder relationships to enhance patient safety and technical assessments.
Highest-signal resume keywords
Quality Management Systems (QMS)Design ControlsISO 13485ISO 14971Leadership Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Risk ManagementProcess OptimizationTechnical AssessmentsCAPA ComplianceCost Modeling
Soft Skills
Stakeholder ManagementCommunication SkillsCollaboration
Industry Keywords
Regulated IndustryManufacturing QualitySupplier QualityGlobal RegulationsCross-Functional Partnerships
About the role
Key responsibilities & impact- Perform patient safety and technical assessments of acquisition targets during due diligence and post-acquisition assessment periods
- Identify quality system, product, process, design control, and risk management gaps
- Lead quality functions in creating cost models to support integration and remediation
- Support development and execution of risk- and time-based integration plans
- Address CAPA compliance findings
- Support QMS and IT integration
- Coordinate remediation activities
- Establish and track high-risk key process indicators related to patient safety, technical, and compliance risk reduction
- Build collaborative relationships with cross-functional stakeholders
- Coordinate and collaborate remotely with multidisciplinary teams across time zones and geographies
Requirements
What you’ll need- Bachelor’s degree with 7 years of work experience in Quality and/or experience in a regulated industry plus 5 years of leadership experience OR advanced degree with 5 years of work experience in Quality and/or experience in a regulated industry plus 5 years of leadership experience
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
- Strong knowledge of Design Controls, Manufacturing Quality, Supplier Quality, and Global Regulations and Standards (e.g., ISO 13485, ISO 14971)
- Ability to build and influence cross-functional, multi-site, and geographically diverse partnerships
- Excellent stakeholder management and communication skills
- Proven ability to lead meetings and engage internal teams, external customers, and vendors
- Track record of establishing, improving, and optimizing processes and systems
- Strategic leadership and execution-focused decision making
- Unrestricted U.S. work authorization at the time of hire and for the duration of employment
Benefits
Comp & perks- Competitive Salary and flexible Benefits Package
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)