Job Information
Actalent Senior Quality Engineer in Elkton, Maryland
Job Title: Senior Quality Engineer
Job Description
As a Senior Quality Engineer, you will proactively investigate, identify, and implement best-in-class Quality Engineering practices. You will provide focused quality engineering support and assume responsibility for timely and effective coordination and execution of assigned development project activities. Your role will include establishing effective corrective action plans, leading the implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements. You will also act as an effective leader or team member in supporting quality disciplines, decisions, and practices, and apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Responsibilities
Review and approve product and process qualification and validation and other change control related documentation.
Develop product/process assurance plans, which include all required elements.
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
Generate internal quality documentation such as quality plans, standard operating procedures, and inspection procedures.
Participate in Product Review Boards and identify non-conformance trends, developing technical investigation plans.
Investigate and analyze customer/internal complaints.
Perform analytical measurements and experiments to qualify or resolve product and process issues.
Develop and implement strategic quality plans, master validation plans, validation protocols, inspection plans, and quality/regulatory compliance operating procedures to meet FDA and ISO requirements.
Track quality trends and initiate action items to resolve issues.
Manage assigned corrective actions.
Monitor field quality and analyze field returns to determine root cause.
Provide training and support for quality system processes and quality engineering practices.
Essential Skills
Bachelor's or higher in an engineering discipline, preferably Quality Engineering.
8+ years of experience in medical device or highly regulated industry.
Experience in a fast-paced setting where thousands of units are quality checked daily.
Knowledge of national and international regulations applicable to medical devices including Quality System Regulations, 21 CFR 820, 21 CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO, and MDD 93/42/EEC.
Proficiency in communication, both verbal and written.
Strong problem-solving and critical thinking skills.
Detail-oriented with initiative and decision-making capabilities.
Results-oriented, self-motivated, and self-driven.
Excellent organizational and time management skills.
Excellent computer skills.
Good writing, mathematics, and statistics skills.
Additional Skills & Qualifications
Audit management experience.
Experience with control plans and their application.
Work Environment
You will be working in a high-volume manufacturing environment focused on new product development. The facility spans over 100,000 square feet and includes 10 products with different SKUs and sizes, primarily in vascular access, closure, catheters, and embolics. Some products have production volumes reaching up to 2 million units. The environment is dynamic, fast-paced, and involves working with advanced medical devices such as vascular closure devices.
Pay and Benefits
The pay range for this position is $86600.00 - $129800.00/yr.
We provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include: paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Pay range is $86,600 - $129,800
Workplace Type
This is a hybrid position in Elkton,MD.
Application Deadline
This position is anticipated to close on Apr 28, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.