Quality Analyst (Hiring Immediately)

Responsibilities

Collaborate with engineers to create complex change request packages and assess impact of the proposed change by performing thorough impact assessments utilizing PLM.

Provide technical guidance using moderately complex knowledge of product lines to implement changes in drawings, parts, documents, protocols, and risk management in a timely manner utilizing PLM.

Develop technical justifications and other content for engineering change submissions.

Evaluate and analyze moderately complex technical information and data related to production quality indicators, identify trends and driving factors, and recommend course corrections.

Create presentations and present summaries of trends, potential root causes, and recommended course corrections.

Draft updates to Quality procedures (e.g., inspection improvement initiatives) and conduct reviews to finalize procedures.

Contribute process knowledge to and develop proposed modifications to resolve open issues on Quality, Engineering, and Manufacturing projects as part of cross‑functional technical groups.

Develop and present training materials for quality system related processes.

Other duties assigned by Leadership; support corporate‑level project management, including support in continuous improvement projects.

Requirements

Bachelor’s Degree in a related field or equivalent work experience.

3 years of related experience or equivalent work experience.

Experience working in a medical device, healthcare, or a related environment.

Proven expertise in MS Office Suite, Windchill PLM or equivalent.

Good project management skills and related software tools preferred.

Excellent written and verbal communication skills, including negotiating and relationship‑management skills.

Good problem‑solving and critical‑thinking skills.

Knowledge and understanding of company policies, procedures, and guidelines relevant to quality compliance.

Knowledge of Good Documentation Practices (GDP).

Full understanding of medical devices regulations (e.g., FDA 21 CFR Part 820 and ISO 13485).

Strict attention to detail.

Ability to interact professionally with all organizational levels.

Ability to manage competing priorities in a fast‑paced environment.

Must be able to work in a team environment, including inter‑departmental teams and representing the organization on specific projects.

Ability to build productive internal and external working relationships.

Ability to adapt to new technologies and a rapidly changing environment.

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as in protecting the environment and preventing pollution within their span of influence/control.

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