Amphenol FSI: Quality Manufacturing Engineer

Position requires candidates to be U.S. person as defined in ITAR, 22CFR 120.15 (U.S. Citizenship or Resident Alien Status)

Amphenol Fiber Systems International (AFSI) is a full service fiber optic company specializing in the fabrication of manufacture of fiber optic connectivity products and systems.  Our commitment to technical excellence makes us an industry leader in proficing sophisticated products and professional technical assistance in the fiber optic industry.  AFSI, located in Allen, Texas, has and will continue to base its strategy on technical and application support, quality assurance, product performance and value.

The Quality Manufacturing Engineer is responsible for understanding and interpreting all customer requirements to the Organization’s operations, and ensuring that the organization manufacturers product that meets or exceeds customers’ expectations. Position requires breadth of experience across multiple programs, products and customers to determine the right level of actions to improve / maintain the customer experience in all situations.

 Essential Functions:

  • Review customer drawings, specifications and contracts; interpret customer requirements and flow them down to the appropriate functions in the organization
  • Primarily responsible for understanding all customer requirements and communicating them during bid and contract reviews
  • Conduct FAI review and assessment
  • Conduct drawing reviews; audit Organization’s production drawings against customer drawings and requirements
  • Coordinate failure analysis; ensure true root cause identification and appropriate correct actions
  • Manage coordination of improvements; standardizing workmanship across the organization
  • Conduct internal quality audits in accordance with internal processes
  • Conduct customer quality audits to include design review
  • Work closely with Product Line Managers on new product introductions and ensuring customer expectations/requirements are met; assist in auditing Qualification Test Matrix against customer requirements
  • Manage documentation organization
  • Facilitate customer training
  • Some minimal travel may be required

Required Knowledge, Skills, and Abilities:

  • Proactive with desire to improve organization performance
  • Familiarity with software development, testing, introduction and upgrades
  • Ability to establish rapport with and elicit cooperation from people at all levels of an organization
  • Strong analytical and organizational skills
  • Strong oral and written communication skills, with the ability to influence & negotiate at all levels
  • Ability to make decisions and excel in situations characterized by uncertainty
  • Familiarity with ISO9000 desired
  • Strong project management skillset; detail oriented
  • Proficient in Microsoft Office (Word, Excel, PowerPoint)
  • Strong understanding of best practices in customer service

 Required Education and Experience:

  • Bachelor’s degree in Mechanical Engineering or related field
  • 2 -5 years’ experience in manufacturing quality engineering, process engineering or product engineering
  • Zero Defect Planning experience
  • Advanced Product Quality Planning (APQP) experience
  • 5 Why root cause analysis experience
  • S. person as defined in ITAR, 22CFR 120.15 (U.S. Citizenship or Resident Alien Status)

 

To apply for this position, please follow this link to complete the application process.  http://www.fibersystems.com/employment/

Senior Regulatory Affairs Specialist – Inogen, Richardson, TX

ABOUT INOGEN 

Inogen was founded in 2001 to improve quality of life and increase freedom and independence for oxygen therapy users. Inogen is innovation in oxygen therapy. The Inogen mission is to improve freedom and independence for oxygen therapy patients through innovative products and services. Inogen is a manufacturer and Accredited Homecare Provider.

Inogen is focused on quality care, continuous improvement, and outstanding customer satisfaction. We are a stable, USA based company dedicated to providing an exciting and rewarding career to our employees. We completed a successful Initial Public Offering on the NASDAQ in 2014 and have demonstrated substantial growth over the last five years. Our work environment is casual yet high performing, and we are looking for seriously talented, motivated, and fast-paced professionals to join our team.

JOB DESCRIPTION 

The Senior Regulatory Affairs (RA) Specialist has responsibility for ensuring organizational compliance with quality and regulatory standards for both product and company operations. The position is responsible for obtaining regulatory clearances/ approvals and overseeing a Quality Management System (QMS) that is in keeping with business objectives and government directives.

Key Competencies:

  • Assist in obtaining all necessary domestic and international regulatory registrations, product clearances/ approvals, certifications and in maintaining documentation needed to support ISO, FDA, and EU/ international compliance, allowing for the sale of Inogen products in US, EU, Canadian and other international markets, as determined by business objectives.
  • Compile, submit, and monitor reports and responses to regulatory authorities and related third-parties.
  • Support regulatory agency and third-party inspections and audits.
  • Maintain/ support the Internal Audit Program company-wide for a fully compliant Quality Management System (QMS) – including within its scope applicable accreditation and Home Medical Equipment (HME)/ Durable Medical Equipment (DME) compliance provisions.
  • Support the Supplier Auditor Program as a QMS Supplier Auditor, as required.
  • Provide company-wide Quality Management System (QMS) training and regulatory expertise, as needed.
  • Support the Corrective and Preventive Action (CAPA) program.
  • Participate in product development activities, including evaluating and advising personnel on regulatory impact throughout product lifecycle stages, ensuring that regulatory-specific (product and process) standards are understood, that a design control system is in place, that design validation activities are conducted, and that a Design History File (DHF) is maintained to support regulatory submissions.
  • Support Engineering efforts with review of technical/ regulatory standards for impact to development/ product.
  • Participate in transfer of approved product design to Manufacturing to meet market introduction and other key milestone target dates, ensuring that a Device Master Record (DMR) is in place (specifications, bill of materials, drawings, material specifications, labeling, etc.).
  • Participate in the development of manufacturing and inspection/ test procedures, including required validations for final product release.
  • Participate in change control activities, such as design changes, manufacturing improvements, new supplier introductions, cost reduction initiatives, etc., ensuring that regulatory standards are understood.
  • Support key business relationships by providing regulatory expertise specific to contract manufacturing and/or private label arrangements.
  • Manage post market surveillance (PMS) activities, including customer complaints/ adverse medical event reporting systems, risk files, etc.
  • Assist with the compilation of Clinical Evidence Reports, as needed.
  • Facilitate Kaizen initiatives to introduce improvements throughout the Quality Management System and/or serve as the Regulatory Affairs delegate for such forums, as needed.
  • Support Operations reporting and trending.
  • Mentor junior staff and manage consultants, as assigned.

 Do you possess these abilities?

  • Knowledge of ISO and FDA regulations required
  • Previous experience in Regulatory Affairs (specifically medical devices) and at least one (1) of the following: product development, manufacturing engineering, quality assurance, or production management required
  • Ability to facilitate external/ internal audits required
  • Attention to detail required
  • Excellent skills with database systems and Excel with capability to compile data from various sources to produce useful reports for trending and verifying process improvements required.
  • Knowledge of DMEPOS accreditation requirements preferred
  • Experience with DMEPOS/ CMS preferred
  • Familiarity with process improvement concepts (i.e. LEAN, Six Sigma, etc) preferred
  • ISO 13485:2016 Lead Auditor Certification and/or ASQ CQA, and/or ASQ CBA preferred

Requirements:

  • BS in Engineering, Biological Science or other technical discipline or equivalent
  • Five (5) years minimum experience in medical device manufacturing environment

WHY INOGEN Inogen is a dynamic company that is not only focused on quality care of patients, but is also committed to being a top employer.  Each of Inogen’ s offices have a casual culture that supports employees being responsible and developing professionals.

We offer competitive salaries and a robust benefit package:

  • Employee Stock Purchase Plan 401 (K) plan available for all employees Health, dental, vision insurance Flexible spending accounts and wellness discount program Life Insurance Long Term Disability Robust paid time off and 8 paid holidays Employee Assistance Program

See the Inogen Team in action:

https://www.youtube.com/watch?v=dKoTMeJf5J4

 

Inogen Where we go to work hard to positively impact people’s lives

 

Inogen is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. The EEO is the Law poster and its supplement are available here: http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm; http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf.  The pay transparency policy is available here: http://www.dol.gov/ofccp/pdf/EO13665_PrescribedNondiscriminationPostingLanguage_JRFQA508c.pdf.

Inogen is committed to working with and providing reasonable accommodations to individuals with disabilities.  If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to recruiting@inogen.net or call (972) 616-5668 and let us know the nature of your request and your contact information.

 

ASQ BioMedical Division and FDA Medical Device Industry Coalition – Big Event – April 15, Dallas, TX

Big Event 2016 – Final Meeting Agenda Posting

Quality System Survival: Success Strategies for Production & Process Control,   and CAPA

Date and Time: April 15, 2016 from 8 a.m. to 5 p.m.

Location: Courtyard Dallas DFW Airport North/Grapevine, 2200 Bass Pro Court, Grapevine, TX 76051 USA.  Telephone (817) 251-9095

Every two years FMDIC, with the participation of ASQ Biomedical Division, hosts the “Big Event”, an educational forum for members of the medical device industry to gain more knowledge on how to best implement quality system practices in their organization to ensure product quality and safety, while meeting the requirements of the FDA regulations.  This year’s event focuses on Production and Process Control combined with CAPA, which remain key warning letter citations for many firms.  This event is an all-day seminar which will feature speakers from FDA, academia and industry giving their thoughts on how to best manage these processes in a manufacturing organization.

Because there is a limited capacity for this event, we recommend advanced registration. Click on the link below to register online and reserve your seat.  Be sure to contact the Marriott Courtyard Dallas – DFW Airport North Hotel to reserve your guest room, if needed, under the FMDIC, Inc. room block to receive a reduced rate as well. 

Registration Fee: Industry $300, Government with ID $200, and Student registration with ID $50. To register online, please visit https://www.123signup.com/register?id=pnrxz. As an alternative, send registration information including the registrant’s name, title, organization, address, telephone and fax numbers, and email address (for each registrant), along with a check or money order (covering all registration fees) payable to FMDIC, Inc., to FMDIC Registrar, 4447 North Central Expressway, Suite 110, PMB 197 Dallas, TX 75205.

If you need special accommodations due to a disability, please contact Staci McAllister at least 7 days in advance at Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204, 214-253-5259, FAX: 214-253-5314, email: Staci.McAllister@fda.hhs.gov.

FMDIC is a non-profit coalition, composed of key employees of the FDA offices in Dallas, officials from the Texas Department of Health, academic members as well as individuals from professional and trade associations representing the medical device industry, including ASQ and the ASQ Biomedical Division.  FMDIC was formed to promote communication, education and cooperation between the regulators and the regulated industry.

Career change in your future?

Our jobs posting service is back on-line and going strong. The format is a little different but easy to navigate.

If you are looking for a new position, click on the CAREER/Career Opportunities tab at the top of the home page, and check out all the new additions.These jobs are not only local, but throughout the US, looking for skills from food to biotech at many different job levels.

Joe Eudy from the Ft. Worth section is also busy posting resumes to our members who want more publicity.  If you have an opening you might want to read through the resumes of those who are already out there. If you would like your resume posted, just contact Joe through the page link and send him an email.  For faster response, please put “ASQ- RESUME POSTING” in the email posting and he will get to it asap.

Happy Hunting!