Sr. Engineer, Production (Technical Writer)

Getinge•Merrimack, NH

2d•Hybrid

About The Position

Senior Engineer, Manufacturing Engineering Technical Writer, is primarily responsible for writing Nonconformance Reports (NCR’s) in a manner that is consistent with the rigorous expectations of medical device auditors from various agencies. This position requires a passion for writing NCR’s, understanding quality requirements, developing and improving processes to meet those requirements, driving internal efforts for root cause analysis and corrective actions, while providing day-to-day support of processes to meet our high standards of quality in producing medical devices.

Requirements

Bachelor’s degree in engineering / science, or advanced degree, or equivalent work experience.
A minimum of 5-7 years of Quality Management Systems (QMS) experience.
Excellent problem solving, communication and writing skills.
Experience in the Medical Device Manufacturing industry or similar.

Nice To Haves

Advanced writing skills that hold up to audit scrutiny.
Advanced analytical and problem solving skills.
High level of attention to detail and accuracy.
Self-motivated, proactive, and comfortable working with limited supervision as skills develop.
Exceptional computer skills, including MS Office applications (Word/Excel), PLM – Agile, and statistical software (Mini-Tab).
Ability to work collaboratively with Production, Quality, ME, Procurement and other cross-functional teams.
Advanced knowledge of Quality Assurance methods, such as process validation, design of experiments, statistical process control (SPC) and protocol/report preparation.
Knowledge of ISO 13485 and 14971 and 21CFR Part 820

Responsibilities

Write complex NCR’s, which include the investigation, product or equipment disposition, actions plans, and closure.
Support crash carts for within the Controlled Environment (CE) as needed.
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet internal and external requirements.
Provide support on CAPA’s.
Engage in in Material Review Board (MRB) activities: including defect disposition, rework and sort instructions, and documentation of nonconformances.
Perform root cause / corrective action analysis of failures in accordance with our corrective action process.
Drive change and continuous improvements primarily within the NCR system.
Provide cross functional support for complex root cause investigations, risk assessments and corrective actions through the NCR or CAPA process.
Collaborate with other Manufacturing Engineers (ME’s) on problem solving and root cause analysis activities.
Partner with ME’s with specific product line production quality issues.
Assess and mitigate risk associated with manufacturing activities related to NCR’s.
Identify, analyze and resolve product and process problems within the NCR system.
Collaborate with quality teams, operations personnel and other stake holders to gather technical information, validate content accuracy, and drive NCR’s to completion.
Drive the reduction of product and process non-conformances.
Collaborate with manufacturing and other cross-functional teams to drive continuous improvement initiatives within the NCR system.
Completes assigned Manufacturing Engineering tasks related to QMS systems in a timely manner.
Deep understanding of the Quality and Regulatory requirements within a medical device manufacturing company.