Packaging/Medical Device Quality Engineer

CSL Plasma; Waltham (MA); On-site; USD 115,000 - 136,000; Full time

Job summary

CSL Plasma is seeking a Medical Device and Packaging QA Staff (Advisor) within the CP/MD QA department. You will ensure that design development activities for CSL combination products meet FDA, EU MDR, and other global regulatory requirements while adhering to Design Controls.

This role involves collaborating with global teams across the product lifecycle, applying risk management (FMEA), validation/verification, and quality engineering techniques, and supporting audits and process improvements

Qualifications

• Bachelor's degree in mechanical or biomedical engineering, life sciences or relevant discipline.
• Minimum 5 years of experience in quality, packaging, engineering or manufacturing in medical devices or combination products.
• Working knowledge of medical device and combination product regulations (21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR) and related quality systems.

Responsibilities

• Serve as Medical Device and Packaging QA Associate on assigned combination product development projects and ensure compliance with FDA and MDR requirements.
• Support vendor management activities: audits, quality/development agreements, and vendor performance monitoring.
• Provide regular progress reports and escalate risks related to Quality System or project status.
• Assist with development and implementation of a quality system compliant with 21 CFR Part 4, MDR and global requirements; update SOPs/WIs/Forms and conduct training.
• Stay abreast of changing regulatory requirements for medical devices and combination products.
• Maintain systems/databases related to combination products (standards list, vendor certificates, test method validation log).
• Conduct root cause analysis and problem solving with recommendations.

Skills

Design Controls

Risk Analysis / FMEA

Validation / Verification

Usability / Human factors

Design transfer

Education

Bachelor's degree in mechanical or biomedical engineering, life sciences or relevant discipline

Job description

As a part of the Quality for Combination Products and Medical Devices (CP/MD QA) department, the Combination Product and Medical Device and Packaging QA Associate will represent Quality in global teams involved in design, development, manufacture and regulatory approval of CSL combination products, which include medical device constituent parts developed to enable convenience, monitoring, compliance and effective outcomes for the lives of our patients. This role is responsible for ensuring that new product development activities for all CSL combination product projects follow a 21 CFR Part 4 compliant quality system. The Medical Device and Packaging QA Staff (Advisor) will serve as a subject matter expert on medical device and combination product requirements in accordance with FDA / MDR regulations, ISO and other standards and industry best practices with the emphasis on Design Control process. This role is involved in quality related activities throughout the entire product lifecycle from product concept through industrialization and post market support. The medical device and packaging Quality Associate will collaborate with the multiple global functions and manufacturing sites.

Reports To: Combination Product and Medical Device QA Lead

Main Responsibilities and Accountabilities:

1. Serve as Medical Device and Packaging QA Associate on assigned combination product development projects. Work with project leaders and both internal and external team members to ensure that all design development work meets applicable FDA, EU MDR, and other global regulatory requirements. Ensure that design development teams follow the Design Controls process and utilize appropriate quality engineering techniques such as risk analysis, statistical data analysis, sampling plan development, etc.
2. Ensure external medical device development and manufacturing partners meet the standards and criteria set by CSL. Support vendor management activities by participating in the audits; reviewing quality or development agreements; monitoring vendor performance.
3. Provide regular progress reports and escalated potential risks related to Quality System and/or project status to Quality management and stakeholders.
4. Assist with development and implementation of the quality system compliant with 21 CFR Part 4, MDR and other global requirements. As assigned, propose improvements to the existing processes, update SOPs / WIs / Forms, develop and conduct training on the modified processes.
5. Stay abreast of changing regulatory requirements for medical device and combination products.
6. Maintain systems / databases related to the combination products, as assigned. Examples may include Applicable Standards List, vendor certificate database, test method validation log.
7. Able to conduct root cause analysis and problem solve issues with recommendations.

Education

Bachelor's degree in mechanical or biomedical engineering, life sciences or relevant discipline.

Experience

Requires a minimum of 5 years of experience as a quality, packaging, engineer or manufacturing professional in medical devices or combination products field. May consider candidates with pharmaceutical, biotech, MedTech or other related background.

Competencies

The Medical Device and Packaging QA Staff (Advisor) should have a working knowledge of the medical device and combination product regulations and requirements, at a minimum, 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, relevant FDA guidance, relevant standards and their application in a compliant QMS. The Medical Device and Packaging QA Staff (Advisor) should have minimum 2 years practical experience in medical devices R&D Quality: design controls, new product development life cycle, requirement specifications, risk management (including FMEA), validation/verification (V&V), usability / human factor studies, DHFs, design transfer. This role requires effective communication and collaboration skills. This role requires assertiveness. This role requires problem-solving skills to allow identifying and resolving problems in a timely manner. This role requires planning / organization skills to allow prioritizing work activities and using time effectively. Experience with developing drug-delivery combination products is strongly preferred. Experience with products that include embedded software, mobile / web apps and other connected health solutions is a plus.

Salary

• The expected base salary range for this position at hiring is $115,000 - $136,000.
• In addition to base salary, total compensation for this role may also include incentive compensation and equity.