Current Open Positions

To apply please send a copy of your resume and cover letter to

Executive Assistant

Duties & Responsibilities:

  • Manage the reception area to ensure effective telephone and mail communications both internally and externally to maintain professional image.
  • Supervise the maintenance and alteration of office areas and equipment, as well as layout, arrangement and housekeeping of office facilities.
  • Manage President/CEO’s calendar.
  • Arrange and coordinate travel for President/CEO and assist with travel for others as needed.
  • Coordinate and prepare materials for Management Review meetings.
  • Draft correspondence on behalf of President/CEO.
  • Negotiate the purchase of office supplies and furniture, office equipment, etc., for the entire staff in accordance with company purchasing policies and budgetary restrictions.
  • Supervise the maintenance of office equipment, including copier, fax machine, etc.
  • Work directly with the Director of Business Development and COO to maintain status of marketing materials.
  • Responsible for taking all meeting notes
  • Responsible for mass mailings
  • Participate as needed in special departmental projects
  • Competencies and Skills:
    • Initiative, Time Management, Organization Skills
    • Good oral and written communication skills
    • Knowledge of Microsoft Office

Supplier Quality Engineer

Position Summary:

The Supplier Quality Engineer will provide tactical process improvement, and change management support to external suppliers (and affected internal groups) in resolving quality, productivity, and routine technical issues related to new and existing suppliers during all phases of the product life cycle. Additionally, this role is ultimately responsible for the management and maintenance of the Supplier Qualification program, including all related activities such as: performance of all supplier quality audits, maintenance of the suppliers score card, maintenance of the approved supplier list, and reporting on various metrics to the senior management team.

Principal Duties and Responsibilities:

  • Complete the analysis and resolution of material non-conformances using various problem-solving techniques in support of Material Review Board (MRB) decisions.
  • Track supplier corrective action Requests (SCAR) including issuance, follow up, and closure activities.
  • Ensure that supplier non-conformance events are closed with a sense of urgency, in a timely fashion, and minimal disruption to manufacturing.
  • Perform qualifications to support changes to existing components or new components and materials.
  • Lead the qualification of new suppliers, new components, and changes by developing and executing, in conjunction with other internal groups, a robust and complete set of plans and requirements for such qualifications.
  • Interfaces with External Suppliers.
  • Maintain a professional, ethical, and credible image with suppliers and internal functions, ensuring that this position is deemed a resource person to Sourcing, Manufacturing, and External Suppliers.
  • In conjunction with Sourcing, initiate supply chain based improvements such as Dock to Stock, cost improvements and consolidation projects.
  • Conduct supplier visits per audit schedule, as needed, and in support of issue resolution with detailed reports and agreed actions in conjunction with the supplier and other internal groups.
  • Manage the maintenance and reporting of monthly (or as needed) quality metrics related to supplied materials (receipt, in-process) highlighting the defect trends, current issues, and action taken.


  • Knowledge of basic quality tools, risk analysis, statistics, design of experiments
  • Expertise knowledge in ISO 9001, ISO 13485 & ISO/TS 16949 requirements
  • Excellent written and verbal communication skills
  • Self-motivated and committed to a team approach
  • Bachelor of Science degree in engineering, physical life sciences, or related technical field with 5+ years of experience in quality in the medical device or automotive industries.
  • ASQ certifications (i.e. CQA, CQE) are required
  • ISO/TS 16949 Lead Auditor certification is a must

This is a full-time contractor role.  Preference will be made to candidates residing in the southcentral region of Pennsylvania.  Send resume to subject PA_SQE

Consulting Roles

Quality Engineers

Regulatory Specialists

CAPA Engineers

Complaint Handling Specialists

Design Quality Engineers

Software Quality Engineers

For the following Industries:

Medical Devices

Food and Beverage




  • Working knowledge in the FDA regulated industries (i.e. Biotech, Pharmaceuticals, Medical Devices…etc.)
  • Must demonstrate expertise in the Medical Device Quality System Regulation (21 CFR 820)
  • Must demonstrate expertise in ISO 13485
  • Ability to apply techniques such as: quality system auditing, inspection methods, statistical sampling plans, gauging studies, design verification and validation, and process validation
  • Ability to apply logic, creativity, and scientific thinking to a wide range of intellectual and practical problems
  • This is not an exhaustive list of qualifications


  • Bachelor’s degree in Quality, Mathematics, Statistics, or Engineering is required. Any relevant certifications are preferred.