Manager Quality Assurance Shared Services
Manager Quality Assurance Shared Services
Posted on :
16-03-2025
Employer Active
1 Vacancy
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Yearly Salary
$ 162000 - 192000
Vacancy
1 Vacancy
Posted on :
16-03-2025
Job Description
Company Overview
Embark on an enriching journey with PROCEPT BioRobotics where our vision mission and values guide everything we do as a company. We are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows we improve the quality of life of patients provide more effective treatment options for surgeons uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career brimming with transformative opportunities that provide continuous career growth opportunities.
The Opportunity That Awaits You:
Do you want to be part of an innovative cuttingedge technology robotics company that is changing how BPH is treated Are you looking to be part of an enthusiastic driven passionate and challenging team who continuously learn from one another Are you a leader who wants to make a difference improve processes and inspire others to achieve challenging goals and objectives Are you detailedoriented At PROCEPT BioRobotics you will have an opportunity to contribute and greatly support our continuous improvement philosophy by being part of our Quality team.
This position will lead improvement projects across the shared services QA organization that require coordination with cross functional stakeholders. The incumbent in this role would lead and support Supplier quality Failure analysis Receiving inspection and other assigned Shared services projects.
Through crossfunctional collaboration datadriven decisionmaking and proactive quality leadership the candidate will play a vital role in shaping the future of quality excellence at Procept
What Your DayToDay Will Involve:
- In collaboration with QA Shared Services Management leadership:
- This role requires a proactive datadriven and innovationfocused quality leader who can drive strategic quality initiatives regulatory compliance and continuous improvement in a fastevolving medical device landscape.
- PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee may occasionally lift and/or move up to up to 50 pounds.
- WORK ENVIRONMENT The employee will be exposed to engineering labs a machine shop and manufacturing clean rooms. The environment subject to moderate noise from machinery (i.e. machine shop equipment the PROCEPT Aquablation unit computer equipment printers etc. for which proper hearing protection may be assigned and worn.
- The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities.
Lead collaboration with Quality Engineering Shared Services teams by developing and executing strategies and projects for Supplier Quality Failure Analysis Receiving Inspection and Department Strategic Initiative Projects ensuring excellence in roboticrelated singleuse devices consumables accessories and capital equipment.
Drive improvement efforts for key quality processes including Corrective and Preventive Actions (CAPA) Supplier Corrective Action Requests (SCAR) and NonConformance Management (NCMR).
Utilize datadriven decisionmaking to monitor performance metrics identify risks and implement effective solutions.
Establish and scale quality support processes for onmarket products by leading teams that troubleshoot and resolve quality issues.
Develop strategies to enhance supplier capabilities and ensure adherence to company policies and regulatory requirements. Oversee periodic supplier audits and ensure timely communication of identified issues.
Collaborate with cross functional teams to conduct thorough product and process failure investigations through NCMRs CAPAs and SCARs identifying root causes and implementing effective preventive actions.
Lead and manage strategic RAQA department projects. Develop longterm roadmaps in collaboration with the RAQA leadership team aligning business and technology strategies to foster continuous improvement and innovation.
Lead shared services validation efforts to ensure compliance product quality and business continuity across various manufacturing and processing environments.
Manage incoming inquiries from healthcare professionals (HCPs) and provide technical support across various topics ensuring compliance and offering guidance on relevant processes and applications.
Communicate updates and project status to senior management and internal stakeholders in a timely manner.
Maintain trained status and comply with all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance.
Understand and adhere to PROCEPT BioRobotics Quality & EHS policies.
Travel up to 10 including domestic and international destinations with potential trips lasting over a week.
The Qualifications We Need You to Possess
- Bachelors degree in engineering with eight 8 years of experience desired or a masters degree in engineering with a minimum of five 5 years of experience desired..
- Strong understanding of 21 CFR 820 ISO 13485 and EUMDR requirements for manufacturers ensuring production operations comply with these regulations.
- Experience with risk management methodologies such as FMEA CAPA and Product Lifecycle Management (PLM).
- Proficiency in quality management systems and statistical analysis tools (e.g. Minitab).
- Demonstrated reasoning ability to apply logical scientific and critical thinking principles.
- Proactive and collaborative leader with a bias for action and results (leaving no stone unturned).
- Strong project management and communication skills with the ability to work across various functions and organizational levels.
- Ability to multitask set clear expectations and deliver results within tight deadlines.
- Experience managing and resolving conflicting product and project requirements while fostering crossfunctional collaboration.
- Excellent interpersonal and communication skills across all levels of the organization.
- Strong ability to establish technical and professional credibility in a dynamic fastpaced environment demonstrating a mustdo attitude.
- Expected to present qualityrelated topics during regulatory audits (FDA MDSAP MDR) in frontroom discussions.
The Qualifications We like You to Possess
- Experience leading technical teams and/or managerial supervisory experience preferred.
For USBased Candidates Only
Work Authorization Status: Citizen / Permanent Resident
For this role the anticipated base pay range is $162000 $192000 per year.
Plus eligibility for an annual bonus and equity/RSUs
Understanding PROCEPTs Culture
At PROCEPT we believe every person matters. Every employee every patient every caregiver. Because we are here to create a revolution and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do while also working together seamlessly for a common goal. At Procept curiosity ingenuity and conviction in the power technology will transform the lives of our patients and providers.
And this doesnt happen by accident. It starts with our live induction program that serves as an incubator for crossfunctional team building an immersion in Procepts history jampacked interactive sessions with executive leadership and a crashcourse in the mission and purpose of what we do. It continues with our oneofakind management program designed to build the best managers in the industry where our people managers across functions come together to exchange ideas and grow as both managers and learners in an environment that challenges supports and broadens.
We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept we push beyond just finding a work/life balance we strive to find a work/life blend a professional world that you are honored and impassioned to belong to one that you can proudly share with your family friends and acquaintances.
An opportunity at PROCEPT BioRobotics wont just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!
BENEFITS OF WORKING AT PROCEPT!
PROCEPTs health and wellness benefits for employees are second to none in the industry. As an organization one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage wellness programs onsite gym a 401(k) plan with employer match shortterm and longterm disability coverage basic life insurance wellbeing benefits flexible or paid time off paid parental leave paid holidays and many more!
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT
PROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race color national origin religion gender gender identity sexual orientation disability genetic information pregnancy age or any other protected status set forth in federal state or local laws. This policy applies to all employment practices within our organization.
PAY RANGE TRANSPARENCY
Procept is committed to fair and equitable compensation practices. The pay range(s) for this role is listed below and represents base salary range for noncommissionable roles or ontarget earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to jobrelated skills depth of experience relevant certifications and training and specific work location. Based on the factors above Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus equity and the benefits listed above.
WORK ENVIRONMENT
Well provide you training for and ask you to maintain trained status for and comply with all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.
Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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