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Supplier Qual Engineer II

Job in North Haven, New Haven County, Connecticut, 06473, USA
Listing for: Planet Pharma
Full Time position
Listed on 2026-05-24
Job specializations:
  • Engineering
    Quality Engineering, Process Engineer
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below

Pay 40-54/h depending on experience.

The Supplier Quality Engineer is responsible for managing finished goods Contract Manufactured (CM) for Robotics Surgical Technologies. Primary duties focus on all QMS related matters pertaining to supplier selection, processing supplier change requests, part/process qualification, manufacturing, QMS development, and technical quality, service, and cost improvements. The role works with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, PPAP, SCR, Quality Plans, Control Plans, and FMEAs.

Top

3 Technical Skills Required for the Role
  • Lead, support, review, and approve supplier change requests (SCR), validation, TMV, PPAP, SCAPA, QMS, etc.
  • Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities; create Quality Plans, Control Plans, and FMEAs.
  • Familiar with medical industry requirements such as ISO 13485 and 21 CFR 820 standards.
Education Required

Bachelor’s Degree in Engineering, Science, Electronics, or a related technical field.

Years of Experience Required

Minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.

Responsibilities

The role ensures that suppliers deliver quality parts, materials, and services. Responsibilities include qualifying suppliers according to company standards, administering a Certified Supplier Program in receiving inspection to ensure cost effectiveness, monitoring parts from acquisition through the manufacturing cycle, and communicating and resolving supplier‑related problems as they occur. The position develops and prioritizes an auditing schedule to ensure designated suppliers are audited regularly to meet GMP and quality standards.

It evaluates suppliers' internal functions, assesses overall performance, and provides feedback on operational assessments.

Specialist Career Stream

Typically an individual contributor with responsibility in a professional discipline or specialty. The role delivers and/or manages assigned projects and works with other stakeholders to achieve desired results. The individual may act as a mentor to colleagues and may direct the work of lower‑level professionals. The majority of time is spent delivering and overseeing projects from design to implementation while adhering to policies and using specialized knowledge and skills normally acquired through advanced education.

Differentiating

Factors
  • Autonomy: Established and productive individual contributor who works independently with general supervision on larger, moderately complex projects.
  • Organizational Impact: Sets objectives for own job area to meet project and assignment objectives and contributes to the completion of project milestones.
  • Innovation and Complexity: Problems and issues faced are general and may require understanding of broader issues; adjustments or recommendations to enhance systems and processes to solve problems or improve effectiveness.
  • Communication and Influence: Communicates primarily and frequently with internal contacts; external interactions are less complex or problem‑solving in nature, sharing information, status, needs, and issues to inform and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry‑level professionals and/or employees in support career stream.
Required Knowledge and Experience

Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience. Requires a university degree and a minimum of 2 years of relevant experience, or an advanced degree with no required years of experience.

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