Associate Quality Engineer Jobs

Mainstay Medical

Mainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system, ReActiv8®, for people with disabling chronic mechanical Low Back Pain. The company is headquartered in Dublin, Ireland, with subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

The Role

The Associate Quality Engineer is responsible for the application and maintenance of quality standards as they apply to Mainstay Medical products. This position will be focused on product release and production and process controls. The quality engineer participates in developing and approving vendor interactions relating to product quality and at times may be in communication with the vendor. This position may at times participate in internal/external and supplier audits. The Quality Engineer will work closely with colleagues across multiple time zones around the world; and have regular contact with operations and other quality team members.

Position Responsibilities

• Supplier Management/Production & Process Controls

• Communicating, and resolving vendor quality issues.
• Resolve non-conformities and manage related CAPA activities.
• Prepare product and process quality reports.
• Perform investigations and when necessary improve procedures and processes.
• Comply with the policies, procedures and work instructions of Mainstay Medical and its subsidiaries.
• Direct interactions with Notified Body, other agencies and vendors during company audits/inspections.
• Ensure compliance with in-process product inspection standards, product rework and dispositions standards by studying manufacturing methods, devising testing methods, and procedures.
• Participate in product release activities for manufactured and purchased products.
• Apply sound systematic problem-solving methodologies in identifying, prioritizing,
• General Responsibilities
  • Comply with the policies, procedures and work instructions of Mainstay Medical and its subsidiaries.
  • Perform investigations and when necessary improve procedures and processes.
  • Direct interactions with Notified Body, other agencies and vendors during company audits/inspections.
  • Thoroughly document all issues related to quality assurance, GMP, and ISO compliance.
• Maintain product quality by enforcing quality assurance policies and procedures and government requirements; collaborating with suppliers and operations when appropriate.
• Apply sound systematic problem-solving methodologies in identifying, prioritizing,
• Thoroughly document all issues related to quality assurance, GMP, and ISO compliance.
• May participate and/or perform vendor audits and qualifications. Participate in supplier approval and management activities.
• Communicating, and resolving quality issues.

Qualifications:

• Bachelors Degree in Engineering (preferred) or Life Science
• 2-5 years relevent work experience in a regulated industry
• Preferred: ASQ Certification, Lead Auditor Certification, ISO 13485 and/or FDA-regulated experience.

The salary range for this position is $72,000 to 82,000/year; however, base pay offered will take into account a range of factors, including job-related knowledge, skills, and experience. The total compensation package includes a range of medical, dental, vision, financial, and other benefits, as well as equity.

Mainstay Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to gender, race, color, religious creed, national origin, age, sexual orientation, gender identity, physical or mental disability, and/or protected veteran status. Mainstay Medical participates in E-Verify.