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Senior Quality Engineer

At Hologic, we're an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we've been able to expand our offerings to empower even more people and champion women's health
What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.
None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.
While we focus on women's health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
Summary
The Sr. Quality Engineer is a key technical role responsible for ensuring all aspects of overall product quality with strong focus on overseeing product transfer from development to manufacturing and continuous product/process quality improvement in manufacturing. The Sr. QE will work to make improvements to the company quality system. The position requires interaction with many internal departments, including Engineering, Manufacturing, Materials, Quality Control, and Customer/Field Service; along with interactions with external entities including contractors, suppliers, and customers.
Essential Duties and Responsibilities
Provide Quality Engineering support to production and Contract Manufacturers production issues. Support Corporate harmonization initiatives at site level. Support implementation of 13485:2016 and MDR updates.
Support Manufacturing Lean initiatives. Participate/ Lead project teams and attend Gemba board meetings.
Provide Quality Engineering support to New Product Development Projects ? Support Risk Management activities, lead review and updates to Risk Management File.
Author, Execute or Approve Process Validation protocols and reports as necessary.
Support Post Market Surveillance efforts as needed
Author, review, approve QC inspection plans for Incoming Inspection
Support, mentor and develop other quality engineers within the group. Provide technical expertise to other members of the quality engineering team. Support the MRB evaluation process. Represent QA on cross-function MRB committee.
Interpret quality data and non conformances. Perform failure evaluations, determine root cause, and implement corrective action. Validate the corrective actions.
Initiate and/or participate in cross-functional teams to support department and company goals. Lead product quality related meetings; follow-up with team members for updates and actions; and distribute meeting minutes.
Working with Design Engineering, Operations, and Supply Chain, establish minimum acceptable requirements for the selection of qualified suppliers.
Assess supplier capabilities through direct visits, technical discussions and quality system assessments. Communicate quality issues to suppliers as needed and provides assistance to develop corrective actions.
Identify, establish, and maintain Quality Metrics and report to management.
Collaborate with development and manufacturing personnel in writing and / or reviewing design verification and validation reports.
Ensure compliance issues are addressed for new and existing product activities. Prepare and update Quality Assurance documents and SOPs.
Review and approve interdepartmental records, documents and SOPs to ensure conformance with the regulations and guidelines.
Assist in the internal audit program to help ensure the compliance of the internal departments to applicable regulations.
Support special project team activities; complaint or CAPA investigations; and product or process risk analyses as needed.
Provide support and guidance to Quality Control and Quality Assurance personnel in setting work priorities and accomplishing daily tasks.
Qualifications
Ability to read, analyze and interpret international and national Quality standards.
Ability to effectively communicate and present information to top management and auditors from various compliance agencies.
Ability to communicate efficiently and effectively with all levels within Quality as well as cross functionally with departments such as Manufacturing, Engineering and Purchasing.
Proficient in the areas of statistical principles and applications; qualitative and quantitative data analysis; DOE, Acceptance and Sampling; process improvement/optimization; gage R&R measuring systems; and system and product audit.
Proficient in manufacturing and quality documentation development
Ability to work independently or under minimal supervision
Understanding of manufacturing processes, challenges, and solutions
Knowledge of Microsoft Word and Microsoft Excel
Working knowledge of statistical programs (Minitab or other statistical packages)
Knowledge of ISO standards for Class II medical devices preferable (ISO 13485, 14971)
Working knowledge of electronic quality management systems and/or manufacturing execution (ERP) systems
Exceptional analytical, electronics and electromechanical aptitude, problem solving, and root-cause analysis skills
Excellent organizational skills
Strong written and verbal communication skills
A Change agent with energy, passion, and enthusiasm to drive change
Supervisory Responsibility
Potential for direct / indirect supervision of QA team members
Supervisory experience is a plus, but not required
Education
Bachelor's degree in Electrical, Mechanical or Optical Engineering preferred.
Experience
Minimum five (5) years of experience in quality, product development or process development within FDA and/or ISO 13485 regulated medical device setting, with hands on knowledge of regulations with minimum of three (3) years in quality is required. Experience in medical devices manufacturing; experience with software driven electro-mechanical medical devices highly preferred.
ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification desired.
Sphere of Influence
This position provides support to internal customers and employees. Highly visible position that interacts with all levels of the Company.
Up to 20% Travel
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.



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