Harvard Bioscience Inc.

Quality Manager

Harvard Bioscience Inc. • $80K — $110K *
St. Paul, MN 55106In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 4-year engineering degree required.
  • 5+ years of relevant experience in quality management.
  • 2+ years of management experience preferred.
  • Full understanding of ISO 9001:2015 required.
  • Experience with ISO 13485:2016 and IEC 62366-2:2015 is a plus.
  • Strong organization, communication, and leadership skills are essential.
  • Knowledge of the full product lifecycle is important.

Responsibilities

  • Support and expand a culture of quality within the organization.
  • Provide mentorship to the quality team and department leads.
  • Manage the Quality Management System to align with corporate needs.
  • Lead execution of the Global Quality Plan.
  • Track regulatory changes and advise on necessary system updates.
  • Plan and execute the Internal Audit schedule.
  • Support validation of manufacturing processes and change control projects.

Benefits

  • Collaborative work environment fostering quality culture.
  • Opportunities for mentorship and leadership development.
  • Engagement with cross-functional teams.
  • Involvement in diverse quality improvement projects.
  • Scope for professional growth in a reputable company.
Full Job Description
POSITION SUMMARY

Harvard Bioscience is looking for a Quality Manager for our New Brighton office. This role is responsible for executing the Global Quality Plan, driving cultural changes toward Quality processes, and collaborating with production, product development, sales/marketing, and post-market teams to ensure connection with processes and data.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Leadership:
  • Support and expand the culture to provide high quality products to customers.
  • Provide mentorship to quality team and department leads.
  • Cultivate collaborative culture across the organization.
  • Manage the Quality Management System architecture to meet corporate needs.
  • Reviews Quality System operation and identifies improvements.
  • Plans and leads improvement projects.

Quality:
  • Leads execution of the Global Quality Plan in Holliston.
  • Tracks regulatory changes and makes recommendations for system changes.
  • Leads the CAPA review board, including field risk assessment.
  • Plans and executes Internal Audit schedule.
  • Responds to external information requests (customers, audits).
  • Provides perspective and experience for information management procedures and tools.

Operations:
  • Supports validation of manufacturing processes.
  • Supports manufacturing change control projects.
  • Reviews exception proposals as part of risk assessment.

Design:
  • Supports project, verification, and design validation planning.
  • Supports design change control projects.


SKILLS AND ABILITIES REQUIRED
  • Strong organization, communication, and leadership skills.
  • Knowledge of relevant manufacturing and process development principles and practices.
  • Project management skills, ability to plan, and perform against plan.
  • Interpersonal and leadership skills with the ability to establish rapport with cross functional team members to create high performance teams.
  • Confidence to provide quality staff direction and assignments consistent with department objectives and priorities.
  • Ability to review the manufacturing processes, design verification plans and reports, and process validation/qualification protocols and reports.
  • Full understanding of ISO 9001:2015 Required.
  • Experience with ISO 13485:2016, ISO 14971:2019, IEC 62366-2:2015 or other regulations a plus.
  • Willing to share knowledge and teach others about processes.
  • Knowledge of the full product lifecycle (Launch/Maintain/Obsolete).
  • Ability to work effectively in a cross-functional team environment.
  • Strong analytical ability with active listening skills.
  • Ability to interpret and articulate regulatory requirements.
  • Ability to lead by example.

EDUCATIONAL REQUIREMENTS AND/OR EQUIVALENT

4-year engineering degree with 5+ years relevant experience and 2+ years of management experience preferred.

FLSA: Exempt

About Harvard Bioscience Inc.

Harvard Bioscience, Inc. is a global developer, manufacturer and marketer of a broad range of specialized products, primarily apparatus and scientific instruments, used to advance life science research and regenerative medicine. Our products are sold to thousands of researchers in over 100 countries primarily through our dedicated direct sales force. We are a leader in the market segments we serve, with a focus on improving the accuracy and efficiency of research, including in drug discovery, neuroscience, stem cell research, cell biology and regenerative medicine. Our product portfolio includes over 10,000 products marketed under well-known and respected brand names such as Harvard Apparatus, Denville Scientific, and BTX. We have a diverse customer base, including leading research institutions, pharmaceutical and biotechnology companies, academic and government laboratories, hospitals and reference laboratories.
Learn more about Harvard Bioscience Inc.
Size
475 employees
Market Cap
$106.7 million
Industry
Healthcare
Net Income
-$7.8 million
Founded
1901
5 Year Trend
+2.6%
Revenue
$102.1 million
NASDAQ
HBIO
* Ladders Estimates

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