Erika Merrick Email & Phone Number

United States

Humlebæk, Denmark, Dk

Humlebæk, Denmark, Dk

Humlebæk, Denmark, Dk

Leading projects across the organization including: business development, R&D new product development and product extensions, enterprise business optimization projects, and Quality Systems projects.

Marlborough, Ma, Us

• Manager of a global team responsible for Quality System functions including complaint handling and MDR/MDV regulatory reporting. • Led the development of a resource capacity model to monitor, project, determine Quality System resource requirements, and to identify opportunities for cross-functional interoperability. • Led the development of a process monitoring model that drives continuous process improvement and waste elimination. Awarded Value Improvement Project Bronze Achievement Award for operational excellence results including 40% cycle time reduction and 45% open WIP reduction.• Led the development of a product family specific complaint reporting form, responsible for leading a cross-functional team to meet complex customer, regulatory, trending, design assurance, and post market quality process requirements.• Managed post-market quality system integration activities to support new acquisitions.

• Manager of a global team responsible for Quality System functions including Training, CAPA System, Complaint Handling, Returned Device Analysis, and MDR and MDV Regulatory Reporting. • Program Manager for large-scale, global outsource engagement. Directed outsource engagement exit to meet board business requirements that ensure compliance and resource retention while meeting aggressive business closure requirements.• Defined CAPA portfolio management strategy following company divesture.• Presenter at Quality Management Review and owner of the CAPA Review Board.• Responsible for budget planning and oversight for managed functions and outsource engagement.

• Served as Vice Precedent of Quality and Regulatory delegate and member of a cross-functional project leadership team for a complex, large-scale enterprise CAPA, risk management, and design file remediation project to address an FDA warning letter.• Project Manager for design file remediation and quality system tool validation initiatives accomplished by leveraging a cross-functional, global team.• Project Manager for driving Quality System divesture activities for CAPA System, complaint handling, and MDR/MDV regulatory reporting.• Program Manager for large-scale post market quality system business process transition to an outsource agency. Transition deliverables: KPIs, governance, SOW, resource model and requirements, SIPOC, current-state and future-state process maps, performance reports, complaint handling system user requirements, training program, work volume analysis, and business continuity plan.• Directed the development of complaint handling system and process. • Presenter at Quality Management Review and member of executive, cross-functional CAPA Review Board leadership team.Project Manager 6/2012 – 10/2013• Project Manager for Process Excellence business transformation / optimization projects that streamlined the post market Quality processes and addressed compliance gaps, supported transition from a paper-based process to an electronically supported process, and optimized to reduced waste.• Project Manager for the development of a complaint handling and MDR/MDV training program.

Minneapolis, Mn, Us

• Executed product complaint evaluations, investigations, and documenting investigation findings and conclusions.• Conducted MDR and MDV reportability determinations and submitted required world-wide reports. • Supported post market Quality harmonization projects with other sites, corporate and European facilities.

Minneapolis, Mn, Us

• Project manager for large-scale, high business-impact product safety recalls throughout the supply chain, in stores, and with Consumer Product Safety Commission.• Led product safety issue management and resolution. Led cross-functional executive leadership groups to communicate investigation and root cause findings, propose and recommend solutions, develop regulatory reporting strategies, draft recall press releases, and draft internal high-level executive communication.• Led collaborative negotiations with cross-functional internal and external partners including legal, buyers, product designers, quality assurance, off-shore vendors, NGOs, and regulatory agencies including the Consumer Product Safety Commission to resolve product issues including product recalls.• Developed an executive communications strategy for high-impact product issues.• Collaborated with off-shore team to develop a solution to automate complaint monitoring and trending.

Minneapolis, Mn, Us

• Project manager responsible for the development of a competitive bid process used with legal vendors to control cost. Customized the legal docketing system to facilitate the process. Process enhancements savings of $600K within 6 months.• Collaborated with paralegals, administrative assistants, attorneys, inventors from cross-functions, and outside counsel to forge strong partnerships that ensured patent reviews and filings were executed in a timely manner and at a competitive rate.• Developed an inventor recognition program for inventors listed on patents.• Managed outside counsel to ensure work was executed on time and within budget.

Bachelor Of Science

Cppm, Project Management

Mini Master In Lean Enterprise

Prosci Certified Change Practitioner

Certified Scrummaster

Quality Systems Requirements And Industry Practice Certificate

Root Cause Investigation For Capa

Cmii And Ipe Bootcamp For Management