Associate Director of Design and Software Quality

POSITION SUMMARY:

The Associate Director of Design and Software Quality is responsible for leading and developing the Design Quality and Software Quality teams. This associate director is a key leadership quality for developing and enforcing efficient and compliant processes for design controls and software life cycle development. As the chief subject matter expert for design control, risk management, and verification/validation testing, this position would have daily influence over product development and change management for Invitae’s IVD products.

RESPONSIBILITIES:

• Participate in project governance operating mechanisms to ensure a consistent and decisive design quality voice is available to all project and initiative execution matters.
• Oversee managers on the Design Quality and Software Quality teams as they develop engaged and effective teams.
• Act as a key escalation point for resolving disagreements or particularly complex issues in a professional and strategic manner.
• Assist with the practical elements of hosting audits and inspections, as well as acting as a subject matter expert for ArcherDX’s compliance to design control, risk management and V&V traceability.
• Contribute to the development of an efficient and agile process for change control to ArcherDX’s platform-based product post-launch. Following implementation of the process, act as contributor, voter and champion of the process’s ongoing needs.
• Plan, predict and execute on resource planning across the Design Quality and Software Quality to support all product development, process development and change management needs for the IVD portfolio of products. Utilize flexible resources where necessary with cost efficiency and accountability.
• Participate in OKR and key initiative planning each year to speak for the assay design and software life cycle needs and priorities at an organizational leadership level.
• Collaborate within the Quality Assurance team to provide expertise on areas including, but not limited to: device design, design validation, risk management and verification and validation. Also, provide key inputs on Quality System success metrics on a regular basis and speak to those metrics in Quality Management Review.
• Collaborate outside the Quality Assurance team with other functional managers on project governance, proposal review, due diligence, special projects, and other duties to be specified by the position’s management.

EXPERIENCE

• Minimum 10 years of experience in the medical device industry advising teams in a design quality capacity.
• Four or more years of experience managing direct reports and resolving both employment issues as well as escalations from functional partners.
• Four or more years experience working with diagnostic products, preferably with exposure to pharmaceutical partnerships.
• Strong instincts for systems engineering incorporate multiple key attributes into a well-documented medical device platform. 
• Strong working knowledge of 21 CFR 820, ISO 13485:2016, IEC 62304, risk management practices and DHF development.
• Collaborative and positive attitude.
• Working knowledge of global regulatory submissions and typical content included therein.
• Direct experience being interviewed in inspections and audits, and familiarity with audit support practices.

KEY ATTRIBUTES

• Must be hands-on, self-directed, organized and conscientious;
• Demonstrated hands on change management leadership skills;
• Excellent written and verbal communication skills;
• Problem solving prowess in consistently evolving environment;
• Proven ability to work under pressure and with short deadlines to accomplish objectives;
• Ability to communicate effectively with technical and non-technical personnel.

EDUCATION 

• Bachelor’s degree in a molecular biology, engineering and/or relevant scientific discipline. Advanced degree preferred.
• Knowledge of manufacturing in a regulated environment (ISO 13485, 21CFR820, cGMP) and related manufacturing and process control requirements.