Manager, Quality and Regulatory

About Medicom

Do you think you have what it takes to work in an organization where creativity, ambition and initiative are valued, and where integrity drives everything we do?

Medicom has been in business for over 35 years, and it has kept its entrepreneurial mindset. Working with us, you will have the opportunity to get involved, have an impact, and contribute to the company's continued growth. We live by our values every day, focussing on customer satisfaction while ensuring teamwork, accountability, and empathy in everything we do.

Our team loves challenges and a fast-paced environment. You will have the flexibility to manage work and a personal life, as well as your own personal well-being. We offer an attractive compensation package with benefits.

The Opportunity

Deliver leadership and management of the MML Quality and Regulatory function for all start-up operations and business initiatives. Lead and manage MML quality teams to facilitate achievement of functional and overall business objectives. Define and implement quality/regulatory processes to support and enable production start-up operations while ensuring stakeholder requirements are met. Utilize risk-based critical thinking leadership approaches to assure compliance with quality/regulatory requirements while simultaneously meeting business objectives. Drive implementation of functional strategy and roadmap, and identify and define quality and regulatory compliance requirements for MML operations to stakeholders throughout the company. Drive continuous improvement initiatives that align with corporate objectives and business strategy while fostering a quality-first culture in start-up project. Uphold Medicom's mission and MML's quality policy while maintaining core values of teamwork, accountability, empathy and customer centricity.

What You Will Do

• Leadership and management of the MML Quality and Regulatory function and team to support the achievement of business objectives per function organizational strategy and internal Medicom standards.

• Implement risk-based quality initiatives to support quality/regulatory compliance, production, supply chain, and operational excellence.

• Lead, coach, mentor and develop high-performing MML quality team with emphasis on standardization and consistency of function organizational operating model.

• Facilitate compliant, efficient and risk-based execution of top-level and sub-level processes as applicable in areas of Quality Governance, Quality Systems and Compliance, Design Quality, Regulatory, Supplier Quality and Quality Operations.

• Assure quality throughout product realization process including ownership of inspection, QA/QC, product release, quality engineering, non-conformance, production process validation, equipment qualification, analytical method validation, and CAPA processes

• Ensure quality objectives align with ISO 13485 and FDA QMSR requirements by integrating key compliance and performance trends. Develop, monitor, and maintain KPIs to assess and enhance quality operations, driving timely corrective actions for underperforming areas.

• Serve on MML Leadership Team with responsibility to lead the collective business, set and maintain strategic direction, and direct teams to ensure achievement of strategic and operational business objectives.

• Drive QMS process development, QMS continuous improvement and standardization to serve business objectives.

• Ensure all process and computer software assurance validation activities for MML align with ISO 13485 requirements and internal standards.

• Lead and drive to completion new ISO 13485 MDSAP QMS certification of MML site. Serve as a primary liaison during ISO 13485 surveillance audits, FDA inspections, and customer audits.

• Lead implementation and maintenance of Medicom standard eQMS system for MML site.

• Support QSC internal audit program, ensuring gaps are proactively addressed through CAPAs and continuous improvement efforts.

What You Bring

• Bachelor's degree in engineering, life sciences, quality/regulatory or related technical discipline

• 10+ years of experience within the quality/regulatory/compliance discipline, preferably in a regulated medical device industry

• 5+ years of management experience

• Demonstrated history of successful compliance leadership, with expertise in ISO 13485 implementation and maintenance.

• Strong experience with eQMS implementation, digital quality metrics, and automation of compliance tracking.

• Proven ability to apply a risk-based approach to quality management, ensuring compliance while optimizing operational efficiency and mitigating potential risks.

What We Offer Compensation

The expected base salary range for this position is $126,933 - 145,067 per year.

Actual compensation will be determined based on experience, skills, education, internal equity, and other job-related factors permitted by law.

Depending on the role, the position may be eligible to participate in a bonus or incentive program.

Benefits & Work Environment

• Comprehensive insurance program including EAP and telemedicine for you and your family.
• Company-matched retirement plan.
• Opportunities for training, coaching, and professional development.
• A dynamic and friendly work environment, with an active social committee organizing events such as sports activities, BBQs, and family gatherings.

Working Conditions & Physical Requirements

• Work is performed in a combination of office and manufacturing environments.
• The role requires regular on-site presence in production areas and extended periods of computer and screen use.
• Standard work schedule is daytime hours; however, occasional attendance outside regular hours (including early, late, or shift-based hours) may be required to support commissioning, operational needs, or improvement activities.
• Occasional travel may be required based on business needs

Equal Opportunity Employer

Medicom is an equal opportunity employer. We consider all applicants without regard to age, gender, gender identity or expression, sexual orientation, race, ethnic or national origin, religious beliefs, sex (including pregnancy and breastfeeding), disability or marital or family status. We welcome applications from all qualified individuals and encourage Indigenous persons, persons of color, LGBTQ+ and gender-nonconforming persons, persons with disabilities, women, and members of any other marginalized group.

Medicom is committed to providing an accessible recruitment process. We will make reasonable efforts to provide accommodations to applicants with disabilities during the recruitment process. If you require an accommodation, please let us know when you are invited to participate in the selection process.

Medicom may use artificial intelligence (AI) and digital tools to support certain aspects of the recruitment process, such as candidate sourcing, screening, and interview scheduling. These tools are used to assist our recruiters and do not make final hiring decisions.

If you are energetic, committed to making a difference and love challenges, we would love to hear from you. Visit our website at Careers - Medicom and apply today!