Senior Manager, Quality Assurance
Microsurgical Technology, Inc. (MST) is seeking a Quality Assurance Manager to join our Redmond, WA headquarters. The Quality Assurance Manager has primary responsibility for the development, implementation, and improvement of the MST Quality Management System including QA, QC and Quality Engineering functions. Reporting to the Sr. Director Quality and Regulatory, the Quality System Manager has exceptional leadership, technical and change management skills to deliver superior results and foster a culture of quality. The position may be required to perform all, or a combination of the following essential responsibilities as determined by necessity.
MST is on a transformational journey to propel ophthalmic surgeries and therapies to a new horizon of patient care by providing innovative smart surgical tools and devices that assist and empower clinicians, digital knowledge base systems that inform and enable decisions, and automation technologies that improve healthcare outcomes while reducing costs. MST is seeking exceptional leaders in all aspects of operating its enterprise from strategy through execution to lead this transformation. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
- Primary systems responsibility for the management and continual improvement of document control, training, CAPA, NCMR, internal and external audits, labeling, risk management, data analysis and Quality System KPIs.
- Leads the Quality Engineering department including Supplier, Operations and Design Assurance.
- Ensure system compliance is in state of audit readiness to meet regulatory requirements (ISO 13485, MDSAP, EUMDR 2017/745).
- Manage aspects of external audits such as front and back rooms, evaluating responses and issuing and closing audit CAPAs.
- Manages Internal Audit Program, conducts audits, plans for corrective and preventive actions related to internal audit findings or gaps identified in the QMS.
- Write, review, analyze and revise Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
- Strategize quality improvement activities in collaboration with other departments.
- Serves as Subject Matter Expert (SME) in Quality by maintaining a high level of expertise in current regulatory requirements.
- Lead site training for various quality systems; coach and mentor individuals and teams in root cause investigations and Quality System requirements.
- Serves as local administrator for manual and electronic quality systems.
- Manage activities of self and direct reports in achieving defined quality goals in an efficient, accurate and timely manner.
- Provide detail analysis of the QMS KPIs for management review meetings and other platforms as needed.
- Ensures KPIs are met by working to overall plan, including management of, and report in.
- Balance cost, quality, people, and delivery objectives to meet plant goals utilizing standard enterprise management system.
- Establishment and continuous improvement of procedures and methods.
- Supervision and development of personnel in QA department
- Other duties as required
- 6+ years of experience (3+ years in management role) in a Quality System or or Quality Engineering role in a medical device design and manufacturing company; MDR Experience preferred.
- BS in mechanical engineering, scientific or relevant technical field
- Excellent communication and teamwork skills
- Ability to work “hands-on” in addition to filling a management role
- Strong analytical, statistical methods (minitab), and structured problem-solving skills
- Energy and enthusiasm for helping patients, surgeons and making MST a great place to work.
Pay range for this exempt position is $140K – $160K/year. The pay range is the general base range for a successful candidate in the State of Washington. The successful candidate’s actual pay will be based on various factors, such as work location, qualifications, and experience.
This role is also eligible for a competitive benefits package that includes medical, dental, vision, life, and disability insurance; 401K retirement plan; flexible spending and health savings account; at least 9 paid holidays; paid time off; parental leave; employee assistance program and other company benefits.
Microsurgical Technology Inc. is an equal opportunity employer and does not discriminate based on gender, sex, age, race and color, religion, marital status, national origin, disability, sexual orientation, gender identity or expression, veteran status, or any other category that is protected by applicable law.
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