Quality Manager, Device R&D

Teva

Runcorn, United Kingdom

The role assures that project output meets combination product regulatory requirements. This position assists in the development and implementation of site/Global QMS GMP policies and procedures. Additional responsibilities will ensure departmental compliance in generating and maintaining design control files (DHF’s, DMR’s).

Essential duties and responsibilites

Provide quality compliance & guidance support for local/satellite R&D teams as required. Perform review and approval authority on project documentation in partnership with internal business partners and external business partners (product design specifications, drawings, plans/protocols/reports related to design verification/validation, method validation, change controls and other documentation) to confirm that the output meets combination product regulatory requirements;
Actively participates in the development/maintenance of the QMS in support of design control development of combination products & devices;
Identify, recommend, communicate, and follow-up compliance and surveillance with R&D/laboratory business partners in events such as deviations, CAPAs, lab Investigations, change controls;
Work with R&D staff and business partners (e.g. contract laboratories, CMO’s, CDO’s) in solving complex quality issues affecting laboratory operations and device components/assembly;
Provide quality support for design and/or technical transfer including support in drafting, review, execution, and approval of protocols and reports;
Manage and assure that necessary project development contact and Quality support is maintained with relevant business partners and Teva site teams;
Represent R&D Quality in design decisions with business partners;
Perform internal/external audits onsite and offsite as required;
Communicate with management on device development status;
If the position involves management of employees: the manager will actively manage a team of Quality Engineers and provide guidance on their work & development.

Your Skills and Experience

Do you have?

Degree in an appropriate scientific or, engineering discipline:
- Ideally, Higher level (MSc/PhD) in the required scientific/engineering discipline, or pursuant to or achievement of a higher level degree.
Significant experience in the field of medical device/combination products GMP;
Deep knowledge and expertise across relevant device regulatory such as ISO13485, 21CFR Part 4/210/211 820;
Full lifecycle R&D/design development of medical devices/combination products;
Project experience of a diverse team;
Auditing (internal) experience.;
Ideally bringing leadership experience;
Well-developed organisational skills;
Excellent communication skills.