Job Information
Digital Prospectors Principal Design Quality Engineer in Merrimack, New Hampshire
Principal Design Quality Engineer
Merrimack, NH
Job Type: Direct Hire | Recruiter: Christie Spencer (https://digitalprospectors.com/our-team/christie-spencer) | Phone: 603.609.7082
Position: Principal Design Quality Engineer
Location: Merrimack, NH (Onsite)
Length: Direct Hire
Job Description:
Our client is seeking a Principal Design Quality Engineer who will work as a member of a cross-functional project team engaged in new product development. The Principal Design Quality Engineer will serve as a quality representative on development projects and will work closely with Engineering, Manufacturing, System Engineering, Software Engineering, and Project Management. The Principal Design Quality Engineer will be responsible for ensuring the product development project is executed and released meeting customer expectations, regulatory requirements, appropriate standards, and company policies and procedures. The Principal Design Quality Engineer will be a key member of the Product Development team and will have the opportunity to influence the product design direction based on the customer’s needs and product reliability expectations and performance.
Essential Duties and Responsibilities (but not limited to):
Serve as a quality representative on project teams engaged in new product development of medical devices.
Support design and development planning, development of design input and design output activities, risk management activities, design history file management, design transfer activities, change management, and design reviews.
Lead quality assurance programs and ensure plans are in place to provide and maintain the quality levels for assigned projects in accordance with contract requirements and product specifications.
Assure the compliance of engineering and manufacturing program documents (good documentation practices).
Ensure products are developed and released that meet customer expectations and regulatory requirements including 21CFR820, ISO 13485, and ISO 14971.
Review and approve design verification and design validation documentation, risk management documentation, product documentation, specifications, and drawings for medical devices.
Support process development, test method development, and associated validation activities.
Use statistical tools and techniques to analyze and evaluate trends, investigate failures, determine root cause, and take appropriate corrective actions to prevent recurrence where appropriate.
Oversee qualification and testing requirements, initiate required customer reports, and lead and support corrective action efforts on failures and defects.
Facilitate integration of new products into manufacturing.
Provide technical support for supplier selection and supplier evaluations.
Work with Quality, Engineering, and Manufacturing to assess the supplier's ability to meet designated specifications and develop quality control plans where needed.
Ensure company policies, procedures, practices, and facilities comply with all applicable customer and regulatory requirements.
Any other emerging quality related duties as identified and assigned.
Qualifications:
Bachelor’s degree in Engineering, Biomedical Engineering, Computer Science, or other technical field.
8 years minimum of related experience in the application of design controls and risk management in the IVD or medical device industries.
Strong knowledge of quality systems, design controls, 21CFR820, 21 CFR Part 11, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, and applicable medical device regulations.
Strong, demonstrated ability to think out of the box to provide technically sound quality assurance and quality system solutions to designated programs to achieve business results and maintain high levels of quality and compliance.
Ability to assess, make critical decisions, and articulate risk when evaluating a situation.
Proficiency in risk management techniques and experience leading others through process mapping exercises and coaching others in problem solving is desired.
Demonstrated experience working with contract manufacturing, suppliers, and customers.
Excellent communication, problem solving, organizational, and interpersonal skills are required.
Green Belt, Lean, Black Belt proficiency is desired.
Professional certifications (CQE, CQA, and CRE) are desired.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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