Global Process Owner, Quality Management Systems - Post Market Compliance
: Job Details :

Global Process Owner for Quality Management SystemsLakewood, Colorado – Must be local hybrid 3 days onsiteDaily Schedule: 8am-5pm MSTSalary range target: $105-130k with 7% bonusKey responsibilities / Must haves:Complaints handling process and revamping processes for complaints handling (global but mostly US regulations)Process improvement and business process improvement.Experienced across all device post-market compliance complaints and ISO 13485.Our client is seeking a highly skilled Global Process Owner for Quality Management Systems with a focus on Post Market Compliance. This senior-level role requires a strong leader who will oversee the development, implementation, and maintenance of globally standardized Quality Management System (QMS) processes.Key Responsibilities: Lead the strategic development and implementation of a robust Quality Management System (QMS) that aligns with regulatory requirements and organizational goals.Interpret and apply global regulations and standards, including FDA, ISO, EU MDR, and other relevant quality requirements for medical devices and combination products.Collaborate and influence global teams to drive alignment and best practices within the QMS framework.Manage and optimize electronic document management systems to ensure compliance and efficiency.Foster a culture of continuous improvement by challenging the status quo and implementing innovative solutions.Engage with stakeholders across all levels of the organization to promote open communication and collaborative problem-solving.Monitor industry trends and regulatory changes to ensure ongoing compliance and readiness.Qualifications: Education: Bachelor's degree in a relevant engineering or scientific field.Experience: Minimum of 10 years in Quality, Regulatory Affairs, Manufacturing, or Engineering roles within regulated industries, specifically medical devices or pharmaceuticals.Expertise: Proven ability to interpret and apply global quality regulations and standards. Significant experience in a manufacturing environment is highly preferred.Skills: In-depth knowledge of QMS frameworks and best practices.Strong strategic thinking skills with the ability to maintain a globally standardized QMS.Exceptional leadership, communication, and interpersonal skills.Growth mindset with a focus on driving continuous improvement.Ability to manage multiple projects and priorities effectively.Proficient in relevant PC software applications, including PowerBI.The company provides competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.#LI-DC1