As a Quality Assurance Officer, you are the guardian of quality and compliance, navigating the complex world of legislation, standards, and requirements for medical device and pharmaceutical manufacturers. Your mission? To uphold and continuously enhance the company's quality system by implementing smart QA processes, supporting departments, and leading improvements like a true quality champion.
Key Responsibilities:
- Advise employees on Quality Assurance Systems.
- Oversee execution according to quality system policies, processes, and objectives.
- Monitor non-QA processes by participating and reporting or approving as an independent party.
- Train staff on Quality Assurance aspects.
- Review measurement and analysis (trend) reports with Quality Assurance relevance.
- Support the organisation during external audits and inspections.
- Coordinate cross-departmental, project-oriented teams.
- Perform QA responsibilities.
- Establish, develop, implement, and maintain QA processes as needed.
- Establish, develop, implement, and monitor progress on quality plans (including related CAPA actions and non-conformity follow-up).
- Support line managers in establishing, revising, implementing, and controlling non-QA procedures.
- Monitor progress according to project or programme plans.
- Deliver regular (trend) reports and on-request reports.
- Set up, deliver, and administer training on Quality Assurance aspects.
- Take on executive, supervisory, and advisory roles within:
- Management systems and processes.
- Validation (processes, products, infrastructure, and equipment).
- Work environment (Cleanroom, ESD, Laser).
- Sterility & sterilisation (Bioburden, Environmental monitoring).
- Deviation management & CAPA.
- Audit & inspection.
- Configuration management.
Skills, Know-How, and Experience:
Education:
- Bachelor Degree (or equivalent ability) in a related field (preferably technical or medical).
Experience:
- 3–5 years of experience in a related field (Medical Devices).
- 3–6 years of general familiarity with:
- Management systems and processes.
- Sterility.
- Deviation management & CAPA.
- Audit & inspection.
- Document & record control.
- Design & development reviews.
- Risk management (including FMEA method).
- Statistical research methods.
Knowledge:
- Familiarity with relevant (inter)national standards and upcoming changes, especially:
- EN ISO 13485 (ISO 9001 with delta training).
- EN ISO 14971, IEC 80002-1, IEC 62366 series / HE 75, ISO 10993 series.
- IEC 60601 series, IEC 60825 series, ANSI Z136 series.
- ISO 14644 series, ISO 14698 series.
- ISO 80002-2.
- ISO 11135, ISO 11138 series, ISO 11607 series, ISO 11737 series, ISO 17665 series, ST79 series, 868 series.
- EN ISO 15223.
- ISO 19011.
- Current Good Manufacturing Practices (cGMP).
Special Requirements:
- Specific know-how of at least one regional set of medical device legislation.
Does DORC International make you happy?
Does working for you mean working together? Realizing surgical devices together that help to make people see again? With a hands-on and both legs on the ground mentality? Do you want to work for an organization where you get freedom and responsibility? Where you are fully stimulated to come up with new ideas? And where innovation, quality and technology are woven into the DNA? Then DORC International is the place for you.
Would you like to know more about working at DORC International? Then read on here.
What does DORC International have to offer you?
At DORC International, you play at top level. It is therefore only logical that we reward you as a top player. You can expect the following:
- Excellent insurance benefits, time off and holiday pay.
- Low-cost Medical (MVI covers 90% of the premium!)
- Employer paid Dental (MVI covers 100% of the premium!)
- Employer paid Life Insurance, AD&D, STD & LTD Insurance
- 401k with generous company match
- Generous Time Off + 10 paid holidays
- Additional voluntary insurance offered such as Accident and Cancer Insurance.
Did you know ...?
DORC, short for Dutch Ophthalmic Research Center, manufactures equipment, instruments and liquids used in eye surgery.
DORC is a ZEISS company, an internationally leading technology enterprise that develops, manufactures and sells highly innovative products and solutions in a variety of business fields, such as medical technology. As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities.
Will you be our new Quality Assurance Officer ?
Are you up for this? Then apply directly via the Apply Now button! Do you still have questions? Please contact Eric Govaarts our Global Recruiter: e.govaarts@dorcglobal.com.
Dutch Ophthalmic USA provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.