Description for Quality Engineer:
This position is self-directed and is responsible for performing Quality Engineering tasks and activities with limited guidance and supervision. Has broad knowledge of commonly used concepts, practices, and procedures within quality assurance field. Relies on personal experience and judgment to perform primary job responsibilities. This role is primarily an Independent Contributor with no direct reports. Interaction is potentially with all levels of the organization.
Responsibilities for Quality Engineer:
*
- Responsible for document review, approval and storage related to assigned projects, such as batch cards, MIs, DHR, DMR, DMF, CAPA, ECO, Validations, IP/PS, customer complaints, FMEA, Customer Proposals, Drawings, Design Control, SDS’, Calibrations, PM, NCR, Product Shipping, and Label Control.
- Participate in customer and regulatory audits as well as internal audits. When trained may be lead internal or external auditor.
- Responsible for the 21 CFR 820, ISO 13485, and cGMP compliance of the assigned PMI programs.
- Participate in project meetings (product design or internal improvements) as Quality representative supporting compliance and PMI Quality position.
- Recommend and implement effective Quality process improvements.
- Participate in validation teams or work on equipment, process, computer systems and automation validations, as requested.
- Support compliance to Good Documentation Practices in document review and approval.
- Multitask, prioritize, and meet deadlines in timely manner without excessive follow-up.
- Exhibit strong organizational and verbal/written communication skills at multiple levels in the organization.
Required Knowledge, Skills and Abilities for Quality Engineer:
- 2+ years hands on experience in a quality role in a regulated industry such as medical device or pharmaceutical
- Skilled with Microsoft Office Software (Microsoft Word, Excel, et. al.)
- Good knowledge of statistics and Mini-tab software
- Good work organizational skills
- Ability to manage time and prioritize
- Excellent communication and interpersonal skills
- Ability to collaboratively interact with people at all levels of the organization
- Good technical writing skills, grammar
- Ability to handle highly confidential business information
- Strong attention to detail
- Ability to think proactively, troubleshoot, investigate and improve systems
- Highly responsible for actions of self and possibly others on the team
Education/Experience Requirements
- Required- Bachelor’s Degree (preferably in Engineering discipline) and 2+ years of Medical Device or Pharmaceutical quality experience
- Preferred – Experience with equipment, process, software, or automation validation and statistical analysis, generating sample plans, scaling up processes, process mapping
Preferred Qualifications
- Experience with equipment, process, software, or automation validation and statistical analysis, generating sample plans, scaling up processes, process mapping
Working Conditions at Poly-Med, Inc.
This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.
Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.
Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Referral program
- Tuition reimbursement
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
Experience:
- validation: 1 year (Preferred)
- FMEA: 1 year (Preferred)
- CAPA: 1 year (Preferred)
Work Location: In person
