Manufacturing Quality Engineer

Manufacturing Quality Engineer

We have partnered with a top company in Andover that is seeking experienced Manufacturing Quality Engineers, ideally with Medical Device experience or Life Sciences experience. In this role, you will support Quality Control in the investigation and resolution of non-conformances in the Medical Device space. You will be working with a team of professionals in a rewarding environment. These positions comes with a competitive salary, annual bonus, outstanding benefits package, and plenty of room for upward mobility. To learn more about these exciting opportunities, apply today, we'd love to meet you!

Duties and Responsibilities:

• Provide quality engineering support in the manufacturing of medical devices & hardware.
• Ensure compliance of manufacturing processes and areas to all applicable quality system regulations
• Lead Nonconformance (NCMR) process such as inspection methods, containment, correction, closure and CAPAs, and drive continuous improvement through analysis of trend data.
• Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities.
• Work with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP)
• Support the inspection & testing of raw materials, components & finished products to ensure compliance with specifications & quality standards.
• Resolve incoming inspection yield issues by driving tighter vendor process capabilities, ensuring appropriate internal drawing specifications, and validation of inspection methods.
• Lead analysis of defective components found in Incoming Inspection and work with suppliers to resolve (SCARs)
• Support internal auditing requirements in manufacturing to ensure compliance with quality system requirements.

Preferred Competencies:

• 3-5 years' experience in a Manufacturing Quality and/or Manufacturing Engineering role
• Working knowledge of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 & 13485 as well other applicable regulations and industry standards pertaining to Medical Devices.
• Experience with manufacturing of complex products in an environmentally controlled area. Experience with medical capital equipment and electromechanical devices preferred.
• Experience with formal problem-solving methodologies and deductive skills, root cause analysis & CAPA.
• Experience with handling non-conforming material and assemblies.

Education:

• Bachelor's in mechanical, Electrical or Biomedical Engineering, scientific or related discipline

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit .

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.