Junior Quality Engineer

Capgemini; Pittsburgh (Allegheny County); On-site; USD 4,140,000 - 6,468,000; Full time

Job summary

Tundra Technical Solutions is seeking a Quality Engineer in the Pittsburgh area to support design quality during new product development. You will lead DFMEA, PFMEA, and risk assessments, ensure V&V alignment with requirements, and drive CAPA and nonconformance resolution.

A strong background in medical device quality, ISO 13485 and FDA QSR is required. Qualifications include a Bachelor's degree in Engineering or Quality and 3+ years in medical device quality engineering, with Minitab

Qualifications

• Bachelor’s degree in Engineering, Quality, or a related field (Master’s preferred).
• 3+ years of experience in medical device quality engineering or related field.
• Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and ISO 14971.
• Experience with Design Control, Process Validation, CAPA, and Supplier Quality.
• Proficiency in statistical analysis tools (Minitab) and problem-solving methodologies (8D, DMAIC).
• Certified Quality Engineer (CQE) or Six Sigma certification is a plus.

Responsibilities

• Supports design quality activities throughout new product development, including design reviews and risk management.
• Lead and participate in DFMEA and risk assessments; participate in PFMEA and control plans.
• Review protocols and participate in V&V planning to ensure alignment with requirements.
• Support testing strategy and equipment qualification and process validation activities (IQ/OQ/PQ).
• Ensure compliance with FDA and international regulations in Design Control.
• Develops supplier qualification processes and PPAPs.
• Develops inspection techniques and implements inspection procedures.
• Manage and drive timely resolution of nonconformances and CAPAs.

Skills

DFMEA

PFMEA

V&V planning

Design Control

CAPA

MSA / Gage R&R

Statistical analysis

CQE / Six Sigma

Risk management

Quality engineering

Education

Bachelor’s degree in Engineering, Quality, or related field

Master’s degree preferred

Tools

Minitab

Job description

Essential duties and responsibilities include the following:

Supports design quality activities throughout new product development, including design reviews, requirements review, risk management, verification and validation planning, and design transfer readiness.

Support design transfer activities by ensuring product and process requirements are translated into manufacturing, inspection, supplier, validation, and release deliverables.

Lead and participate in Design Failure Modes and Effects Analysis (DFMEA) and risk assessments. Participate in DFMEA, PFMEA, process flow, control plan, and risk assessment activities to ensure design and manufacturing risks are identified, mitigated, and documented.

Review protocols and participate in V&V planning to ensure alignment with product requirements. Review verification, validation, inspection, equipment qualification, and process validation protocols to ensure alignment with product requirements, risk controls, and design transfer needs.

Participate in protocol review and support testing strategy, ensuring robust verification and validation processes. Support execution and documentation of equipment qualification and process validation activities, including IQ/OQ/PQ, validation reports, and related production readiness evidence.

Support Design Control activities by ensuring compliance with FDA and international regulations.

Support supplier/process readiness activities, including review of supplier documentation, inspection results, capability studies, MSA/Gage R&R, and approval packages.

Develop and execute supplier qualification processes, including supplier contracts and PPAPs.

Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures and operator self-inspection procedures.

Works with other Quality Engineers and the Metrology Lab personnel on the development of all product gaging.

Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, assists each of these groups with capability studies and the application of statistical quality control.

Interfaces with Manufacturing Engineers to review processes for new products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.

Assists with complaint investigation and documentation interfaces with Regulatory Affairs to support UL, IEC, and FDA submissions. Participates in internal audits conducted by internal employees and regulatory agencies.

Manage and drive timely resolution of nonconformances (NCs) and corrective & preventive actions (CAPAs).

Qualification requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience:

Bachelor’s degree in Engineering, Quality, or a related field (Master’s preferred).

3+ years of experience in medical device quality engineering or a related field.

Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and risk management (ISO 14971).

Experience with Design Control, Process Validation, CAPA, and Supplier Quality.

Proficiency in statistical analysis tools (MinitabJD) and problem-solving methodologies (8D, DMAIC).

Certified Quality Engineer (CQE) or Six Sigma certification is a plus.

Building Strategic Working Relationships-Developing and using collaborative relationships to facilitate the accomplishment of work goals.

Quality Orientation-Accomplishing tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time.

Decision Making- Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.

Performance/Work Standards-Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks. (Flawless Execution of the Basics).

Information Monitoring- Setting up ongoing procedures to collect and review information needed to manage an organization or ongoing activities within it.

The pay range that the employer in good faith reasonably expects to pay for this position is $30.05/hour - $46.95/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.

Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.