Staff Quality Systems Engineer

Job Description

Salary:

About us

Arwood Machine, A VulcanForms Company, is a well-established ISO-9001:2008, AS9100C-certified high-precision job shop in Newburyport, Massachusetts. Founded in 1964, Arwood has continually invested in various new technologies, robotic automation, and machine tools to ensure we remain a world-class, cutting-edge manufacturer.

Arwood Machine, A VulcanForms Company seeks a Staff Quality Systems Engineer for our Newburyport, MA Facility

Job Purpose

As aStaff Quality Systems Engineer, you will be responsible for ensuring the QMS is established and maintained in accordance with applicable medical and aerospace requirements. A candidate must have knowledge of quality systems, CAPA, Nonconformances, Complaints, Internal Audit, and Document Control. QMS compliance will be met by ensuring that activities previously noted are conducted according to prescribed procedures, policies, and regulations.

Key Accountabilities

Ensure that a Quality System is maintained to the highest levels of accordance with applicable regulatory requirements

Write, review, and approve the release of changes to QMS documentation

Own and manage the NCR and CAPA programs

Lead/support significant Quality System projects effectively

Support the internal audit program, the processing of Customer Complaints, the preparation of Management Review, and the QMS training program

Collaborate cross-functionally to ensure accurate, complete, and efficient change processing and document control activities

Support the tracking and trending of quality metrics/KPIs (e.g., CAPAs, NCs, SCARs, complaints, deviations, internal audit findings, calibration and PM, etc.)

Identify areas of improvement through data-driven trending and brings solutions to management

Develop innovative and practical solutions to complex and unique process problems and system improvement through the use of best practices

Identify/escalate any compliance issues and their potential impact and provide potential solutions/actions so that they can be effectively resolved

Support audits and inspections as needed (e.g., coordinate preparation activities, FR/BR support, track resolution activities)

Lead or support additional projects as assigned by QA/RA Leadership

Support/execute other QMS elements as needed

Qualifications

7+ years experience working in the fields of Medical Devices or Aerospace with experience in regulatory requirements, ISO 13485 and AS9100

Experience in writing QMS procedures

Experience in NCR and CAPA

Excellent communication, interpersonal and leadership skills

Experience working with and evaluating Quality metrics and KPIs

Experience leading and influencing across functional groups and leadership levels

Benefits

Medical, dental, vision, and life insurance are available to you starting on your first day of employment

Generous time off package, including vacation PTO, sick PTO, and 14 company-paid federal holidays

401(k) with company match and stock options

Arwood Machine, a VulcanForms company, is committed to being an Equal Opportunity Employer, valuing employees with diverse, multi-cultural perspectives. We are dedicated to fostering an inclusive environment, empowering our team, and embracing diversity. We welcome all applicants and ensure fair and impartial treatment regardless of race, color, religion, sex, national origin, ancestry, citizenship status, age, legally protected physical or mental disability, protected veteran status, status in the U.S. uniformed services, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by applicable federal, state, or local law.