Manager, Device Quality

Job Description

Job Description

Job Title: Manager, Device Quality

Location: New Haven, CT (Hybrid - 3 Days onsite, 2 days remote)

Duration: 10 Months

Bill Rate: $90/hr

This is what you will do:

You shall be responsible for providing compliance oversight of design control and design transfer quality activities associated with medical devices and combination products. This role will also support cross functional activities relating to risk, complaints, investigations, change control and sustaining activities.

Accountable as Quality Key Point of Contact for Medical Device driving excellence in specific GxP processes and procedures partnering with internal or external stakeholders as applicable.

The Medical Device Combination Product Manager is a member of the Global Quality Organisation who is a quality liason between Global Product Development, Regulatory, Manufacturing Operations, Quality Control, and Quality Assurance to ensure regulatory compliance with design control activities and documentation, technology transfer to manufacturing and QC testing processes. The role enables efficient communication and decision making related to the quality and design control of our combination products. The successful candidate shall work in the office a minimum of 3 days per week.

The position reports into the Quality Medical Device leadership team and is a member of the Medical Device Quality Team (MDQ).

You will be responsible for:

• Design Quality Assurance for medicinal combination products and medical devices.

• Support the development of the Design Development Plan in line with applicable regulations for combination products including Planning, Design and Development, Verification, Validation, Technology Transfer and Risk Management.

• Provide Quality oversight for the development, review, and approval of key Design History File deliverables including Verification and Validation Protocols and Reports, Risk Management deliverables, Transfer Plans, Design Reviews, Design History File management and supporting operational procedures.

• Ensuring compliance of test methods for design verification testing, familiar with related standards.

• Support and maintain device QMS to align with standards and regulations.

• Facilitates global and local changes with respect to the product and design control

• Ensure timely entry, processing, and closure of quality records in compliance with Alexion s procedures.

• Attends design reviews and audits design history files (DHF) and corresponding updates and revisions.

• Responsible for understanding when Risk Management File updates are required during combination product lifecycle management and ensuring cross functional teams are coordinated to deliver these updates.

• Reviews and approve CAPA (deviations & actions); includes performing risk assessments, participating in root cause analysis investigations, effectiveness checks.

• Supports Management Review data preparation and presentation.

• Supports regulatory inspections and compliance.

• Supports cross functional activity to ensure audit readiness is in place for all aspects of the product lifecycle.

You will need to have:

• B.Sc. / B Eng degree in Engineering or Science or equivalent experience in regulated industry.

• Preferable 7 years combination product design control and/or medical device manufacturing experience ideally clinical phases through commercial

• In depth knowledge of the regulatory and compliance requirements of medical devices and/or combination products (e.g. FDA QSR 21 CFR Part 4 and 820 / ISO 13485, Regulation (EU) 2017/745, ISO 14971).

• Knowledge of ISO 11608 Needle Based injection systems for medical use would be an advantage.

• Excellent communication and interpersonal skills

• Proven record in demonstrating agility

• Flexibility to travel in support of the role

  EEO:- Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans