Senior Manager, Quality Engineering

Bausch Health•Bothell, WA

12d•Onsite

About The Position

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact. Reporing to the Director of Quality Operations, the is responsible for the management of Quality Engineering team at Solta Medical and is responsible for developing goals, objectives, procedures, policies, and systems that align with FDA/ISO regulations as well as aligns with the company mission and vision. Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

Requirements

Bachelors degree required in a sciences or technical area relevant to the medical device industry.
Minimum of 7 years of medical device industry experience.
Minimum of 5 years of Management experience.
Extensive knowledge and experience with government regulations to assure development of Quality Systems conforming to relevant regulations.
Extensive knowledge of the requirements for international quality systems, including ISO-9001/EN 46001, ISO 13485, MDR, Vigilance Systems, Notified Bodies, CE marking and IEC 60601.
Demonstrated collaboration, team building, negotiation & conflict resolution skills
Knowledge of and working experience with Corrective Action / Preventive Action (CAPA)
Knowledge of and working experience with Supplier Management (Supplier selection / assessments /monitoring / audits / metrics)
Demonstrated knowledge of and working experience with Risk Management (ISO 14971, FMEAs, FMECAs, Hazard Analysis)
Multi-tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow-up skills and ability to hold others accountable.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status
Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations
Ability to write reports, specifications, business correspondence, and procedure manuals
Exceptional analytical, problem solving & root-cause analysis skills. Ability to multitask, define problems, collect data, establish facts, and draw valid conclusions.
Demonstrated ability interpreting a variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Ability to read technical and clinical literature and documents and extract important concepts.

Responsibilities

Attract and retain talent for the Quality Engineering, Supplier Quality, Receiving Inspection teams while also supporting their development
Create a culture of quality that also ensures compliance with QMS, FDA QSR, ISO, MDR, and international requirements
Support audits and inspections by regulatory agencies and notified bodies
Drive process validation, test method development, statistical analysis, and improvement projects
Strategically drive collaboration with CAPAs, non-conformances, and risk management activities that also focus on process improvement
Use high level judgement regarding prioritization decisions, and tradeoffs between schedule, scope, and cost
Partner with R&D, Maintenance, Operations, Quality Assurance and other functions to drive prompt resolution and prioritization of tasks around quality issues for product and processes while also driving the highest quality results
Lead the oversight and influence the nonconformance system (product and non-product related) in a timely manner and serves as an activist and mentor in problem solving and root causing activities
Proactively drive and mentor continuous improvement activities to ensure problems are prevented and issued resolved efficiently and economically