Junior Quality Engineer

TALENT Software Services; Pittsburgh (Allegheny County); On-site; USD 85,000 - 110,000; Full time

Job summary

TALENT Software Services in Pittsburgh seeks a Medical Device Quality Engineer to support design quality activities across new product development, DFMEA, PFMEA, and design transfer readiness.

You will ensure compliance with FDA QSR and ISO 13485, participate in verification and validation planning, supplier qualification, CAPA, and problem-solving using DMAIC; bachelor's in engineering; 3+ years required.

Qualifications

• Bachelor's degree in Engineering, Quality, or a related field; a Master’s degree is 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 ISO 14971.
• Experience with Design Control, Process Validation, CAPA, and Supplier Quality.
• Proficiency in statistical analysis tools (Minitab) and problem-solving methodologies (8D, DMAIC).
• CQE or Six Sigma certification is a plus.

Responsibilities

• Supports design quality activities throughout new product development and design transfer readiness.
• Lead and participate in DFMEA/PFMEA, process flow, and risk assessment activities.
• Review protocols and support verification/validation planning and testing strategies.
• Support supplier qualification, contracts, and PPAPs; ensure supplier documentation and results meet requirements.
• Assist with complaint investigations and CAPA; interface with Regulatory Affairs for submissions.
• Manage timely resolution of nonconformances and drive corrective actions.

Skills

ISO 13485 knowledge

FDA QSR knowledge

EU MDR knowledge

Risk management (ISO 14971)

Design Control

Process Validation

CAPA

Supplier Quality

CQE or Six Sigma

8D, DMAIC problem solving

Statistical analysis (Minitab)

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 (Company) 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

KEY COMPETENCIES: (Leadership skills/behaviors)

• 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.