Marissa Richmond
Hopkinton,MA
Summary
Strategic-thinking individual experienced in building successful & engaged teams. Self motivated high achiever with proven track record of building additional responsibility in diverse areas of science and medical devices.
Overview
26
26
years of professional experience
1
1
Certification
Work History
Director, BSHS QMS
Hologic Inc.
Marlborough, MA
09.2025 - Current
- Optimized organizational design of QMS group leading to focused accountability, increased growth and development and operational efficiency.
- Successfully led back room for FDA warning letter re-inspection 3rd week in role across 14 weeks.
- Scaled QMS remediation team from 1 SME to fully functional team of 26 across CAPA, Management Controls, Document/Change Control and Field Action Execution.
- Establishment of an interim CAPA review board to reduce risk to out of compliance CAPA records where ~77% of records have been pushed back for correction.
- Divisional Management Representative.
- Lead implementation, maintenance and continuous improvement of the QMS and compliance programs in alignment to QMSR, ISO13485 and other regulatory standards.
Director, Advanced Operations
Stryker Sustainability Solutions
Tempe, AZ
03.2023 - Current
- Work closely with organizational leadership and board of directors to strategically affect operational direction
- State licensing representative
- Established a culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.
- Launch of first NPI out of new best cost manufacturing mega site for Stryker (Tijuana, MX)
- Establish a network of key divisional/corporate leaders, academics and supplier partners to facilitate the development and success of the innovation function.
- Partner with mega-site stakeholders to accurately resource & prioritize all new product activities.
- Actively engage divisional and GQO organizations to deliver new products in line with divisional expectations. Develop and maintain appropriate business forums and process improvement initiatives.
- Direct the product innovation teams to work effectively and build collaborative relationships across multiple divisions to improve the speed to market of new products.
- Develop and maintain the functions performance, ensuring learning and development needs are aligned with product roadmaps.
- Foster a culture of collaboration between the global AO teams to ensure that key skill sets can be leveraged when required to ensure projects are managed effectively and delivered in line with divisional expectations.
- Successful launch of first split manufacturing surgical launch for SSS (HAR1100)/
- Responsible for the implementation, enforcement and compliance of all relevant quality, regulatory and safety standards.
Director, RAQA
Stryker Sustainability Solutions
Tempe, AZ
11.2021 - 03.2023
- Worked closely with organizational leadership and board of directors to strategically affect operational direction
- Business Unit Management Representative & site Designated Representative for state licensing
- Management responsibility for all SSS RAQA departments including AQE, Pre Market RA, Post Market Surveillance and Post Market Quality Engineering
- QMS/PMS recently successfully integrated into shared service 7/2022
- Successfully covered 2 additional leader of people positions (Post Market Quality Manager, Laboratory Supervisor) for 3 months during key talent identification/search (20 direct reports during time period)
- Gallup Q12 RAQA managerial mean score of 4.8/5 in first year
- FDA 510(k)clearance of 5 medical devices (VHP POX, Ligasure Small Jaw, Ligasure Exact, RD Sets)
- Oversight of training improvement project (movement to role based curricula's and reassessment of necessary training items) resulting in 2,232 hours & ~$90k in savings
- QMS team implementation of nonconformance monitoring board leading to 416hours and ~$18.5k saved in 6 months (46% reduction in NCs)
- Document control/Change Control First Past Yield Improvement project leading to 50% improvement across the business unit & GQ&O
- Motivated RAQA managers to implement NPD training calendar which resulted in delivery of 28 awareness trainings across 7 NPD departments in 2022.
Director, Pre Market RAQA
Stryker Sustainability Solutions
Tempe, AZ
07.2021 - 11.2021
- Management responsibility of SSS Pre Market RA and AQE groups (2 directs, 15 indirect)
- Interim responsibility of SSS Post Market Surveillance and Post Market Quality groups (2 directs, 17 indirect)
- SSS Management Representative responsibility for SSS division.
Senior Manager, Advanced Quality Engineering
Stryker Sustainability Solutions
Tempe, AZ
04.2021 - 07.2021
- Managed team of 9 quality engineers responsible for risk management, statistical analysis, PPAP, FAI, Supplier Part Certification
- Inspired action for critical lapse in real time aging testing within NPD organization and led working sessions resulting in resolution in 7 months (85 tests across 20 product lines)
- Created AQE optimization hit list to feed into AQE key objectives to facilitatee continuous improvement and leadership capabilities with group.
Senior Manager, Post Market Surveillance
Stryker Sustainability Solutions
Tempe, AZ
03.2021 - 04.2021
- Trained/managed team of 4 for complaint regulatory reporting, PMHRA, field action assessments, field actions & post-market data monitoring, customer escalation/resolution.
Manager, Post Market Surveillance
Stryker Sustainability Solutions
Tempe, AZ
10.2017 - 03.2021
- Trained/managed team of 14 (10 direct, 4 indirect) for internal audits, complaint intake, complaint investigation, complaint regulatory reporting, PMHRA, field action assessments, field actions & post-market data monitoring, customer escalation/resolution
- Complaint data tracking/trending to identify potential product performance issues (>3900 complaints/year; ~ 20,500,000 distributed products/year)
- Successful management of the departmental RAQA budget (>$2 million/year) including but not limited to coordination of training, tuition reimbursement, travel, audit services, dues/publications, employee relations etc
- Gallup Q12 mean score of 4.8/5 in first year with subsequent increase to 4.9/5 second year (97th Percentile)
- Successful maintenance of relevant corporate metrics including but not limited to departmental overachievement for complaint timeliness by 17.8% and field action assessment completion by 34 days
- Successfully drove review, formulation, presentation & execution of a novel Post-Market complaint UCL calculation for the division
- Restructure of UCL mitigated initiation of unnecessary non-conformances while driving identification of necessary non-conformances
- Initiated monthly field sales complaint reporting tool which provides sales regional managers tracking/monitoring for complaint reporting for their teams which facilitated improvement in delayed complaint reporting by 50% within first 6 months
- Supported external audits (FDA, BSI) annually at division site as well as 2 remote, individual manufacturing sites
- Initiated review of historical PFA/PFAA data which identified key areas of focus resulting in a project initiation related to ensuring gaps are mitigated and solutions are sustainable
- Collaborated with Sales/Marketing to address escalated customer issues/concerns internally & externally
- Provided >900 customer success rate reports to relevant field partners to facilitate sales centered customer conversations.
Manager, Technical Support
Luminex Corp
Tempe, AZ
06.2016 - 10.2017
- Trained/managed team of 6 responsible for negligible to high risk complaint investigations
- Scaled from 1 direct report to 6 in less than 1 year (2/6 promoted; 6/6 performance bonuses awarded 2017)
- Optimization/launch of combined complaint handling system 06/2017 within 1 year of integration to streamline 4 major instrument platforms & >16 assays
- Complaint data tracking/trending to identify potential product performance issues (>1800 complaints/year)
- Quality Review Board Member (Review all Quality data sets for optimization/risk evaluation/mitigation)
- Interdepartmental collaboration to ensure products complies with corporate/regulatory body requirements (support/review/input of Health Hazard Analysis, Non-conformances, CAPA etc)
- SME for internal/external audits including successful 2017 FDA audit (allowed removal of warning letter)
- Design/validation/launch of electronic complaint software system 02/2016 from paper-based system resulting in 35.3% reduction in aging complaints within 1 month; 62.1% reduction in overall open complaint numbers and 91.2% reduction in open aging complaints within 1 year
- Generation of customer & internal technical bulletins, departmental SOPs
- Support of significant growth in customer base (>300 customers) resulting in revenue of $30 million/5 Years
- Developed assay lot performance tools to aide in the assessment of potential product performance issues for EP, RP Flex assays (>100,000 avg
- Distributed tests/year)
- Identified 5 new cross-reactions (Verigene BC-GP assay) via complaint investigations which led to package insert update for customer visibility, improved customer expectations/experience.
Manager, Technical Support
Nanosphere Inc
Northbrook, IL
10.2015 - 06.2016
- See above description under Luminex
- Nanosphere acquired 6/2016.
Supervisor, Technical Support
Nanosphere Inc
Northbrook, IL
07.2013 - 10.2015
- Supervised, led and assisted in complaint investigations (low to high risk) within a paper-based system
- Ensured complaint investigations compliant with corporate & regulatory body expectations
- Supported internal/external audits (back room support in FDA audits 2013, 2014) and remediation efforts
- Developed assay lot performance tools to aide in the assessment of potential product performance issues for BC-GP, BC-GN, RV+ assays (>150,000 avg
- Distributed tests/year)
- Complaint data tracking/trending to identify potential product performance issues (>1400 complaints/year)
- Quality Review Board Member
- Responsible for generation of customer facing as well as internal technical bulletins and departmental SOPs
- Supplemental reviewer of interdepartmental SOPs
- Generation of test plan/test reports and execution of plan/reports (>20 projects).
Clinical/Technical Applications Specialist
Nanosphere Inc
Northbrook, IL
10.2010 - 07.2013
- On-site training/troubleshooting SME for growing customer base (733% customer growth from 2011
- Trained/supported customers ranging from small hospitals to large IDN affiliated hospitals (Kaiser Permanente, New York-Presbyterian, Cleveland Clinic, Banner Health etc).
- Company College of American Pathologist (CAP) expert to aide in interpretation of guidelines for customers.
- Completed timely complaint investigations (low to high risk) pertaining to potential product performance issues while traveling 75% of time (North American coverage, no assigned region).
Molecular Laboratory Technician
Metropolitan Medical Laboratories
Moline, IL
08.2009 - 09.2009
- Performed moderate to high-complexity molecular diagnostic tests (including multiplex PCR, real time-PCR, Direct Fluorescent Antibody Testing, microplate assays etc)
- Evaluated/analyzed/reported test results & perform instrument maintenance/calibration (>7 platforms)
- Assisted in departmental preparation for College of American Pathologist inspections.
Program - Instructor
Duke University Talent Identification
Durham, NC
07.2008 - 08.2008
- Graduate research project entitled “Comparison of Differential Processing Techniques for Development of Latent Prints on Porous Substrates”, utilizing current and novel chemical techniques.
Research Assistant-Molecular Ophthalmology Lab
University Of Iowa
Coralville, IA
01.2003 - 07.2007
- Trained personnel in general lab procedures (colleagues, post-doctoral candidates, PhDs etc)
- Performed Confocal, TEM, SEM & associated sample preparations
- Maintained animal & tissue depository, live mouse colonies
- Performed immunohistochemistry research projects using human donor/animal model samples
- Performed SSCP electrophoresis and analysis, DNA extraction, PCR and development of primer pairs and optimization.
Student Research Asst.-Molecular Ophthalmology Lab
University Of Iowa
Coralville, IA
10.2000 - 01.2003
- Trained personnel in general lab procedures (colleagues, post-doctoral candidates, PhDs etc)
- Performed microscopy sample preparation techniques; DNA extraction and electrophoresis
- Dissected human donor eyes for use research projects
- Performed immunohistochemistry research projects using human donor/animal model samples.
Education
Master of Science - Forensic Science
Virginia Commonwealth University
Richmond, VA2009
Bachelor of Arts - Anthropology
University of Iowa
Iowa City, IA2005
Bachelor of Science - Microbiology
University of Iowa
Iowa City, IA2002
Skills
- Corrective Actions
- Quality Assurance and Control
- Quality Management Systems
- Complaint Investigations
- Stakeholder Communications
- Functional and Business Requirements
- Audit Process Management
- Training
- Agile
- Trackwise
- Technical writing/review
- Problem solving
- Strategic planning
Certification
ISO 13485:2016 Requirements (TPECS)
ISO Lead Auditor (TPECS)
Affiliations
Diversity, Equity and Inclusion Council
- Member
SOMOS (Hispanic/Latinx Employee Resource Group) Phoenix Chapter
- Executive Sponsor
SOMOS (Hispanic/Latinx Employee Resource Group) Executive Steering Committee
- Attraction Lead
SEEC (Stryker Employee Events Committee)
- Executive Sponsor
Timeline
Director, BSHS QMS
Hologic Inc.
09.2025 - Current
Director, Advanced Operations
Stryker Sustainability Solutions
03.2023 - Current
Director, RAQA
Stryker Sustainability Solutions
11.2021 - 03.2023
Director, Pre Market RAQA
Stryker Sustainability Solutions
07.2021 - 11.2021
Senior Manager, Advanced Quality Engineering
Stryker Sustainability Solutions
04.2021 - 07.2021
Senior Manager, Post Market Surveillance
Stryker Sustainability Solutions
03.2021 - 04.2021
Manager, Post Market Surveillance
Stryker Sustainability Solutions
10.2017 - 03.2021
Manager, Technical Support
Luminex Corp
06.2016 - 10.2017
Manager, Technical Support
Nanosphere Inc
10.2015 - 06.2016
Supervisor, Technical Support
Nanosphere Inc
07.2013 - 10.2015
Clinical/Technical Applications Specialist
Nanosphere Inc
10.2010 - 07.2013
Molecular Laboratory Technician
Metropolitan Medical Laboratories
08.2009 - 09.2009
Program - Instructor
Duke University Talent Identification
07.2008 - 08.2008
Research Assistant-Molecular Ophthalmology Lab
University Of Iowa
01.2003 - 07.2007
Student Research Asst.-Molecular Ophthalmology Lab
University Of Iowa
10.2000 - 01.2003
Bachelor of Arts - Anthropology
University of Iowa
Bachelor of Science - Microbiology
University of Iowa
Master of Science - Forensic Science
Virginia Commonwealth University