Senior Quality Engineer Job at Katalyst Healthcares & Life Sciences, Newton, MA

b0hZQWdLam4xV0xiL010ZVdLOU1LaW13OUE9PQ==
  • Katalyst Healthcares & Life Sciences
  • Newton, MA

Job Description

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description



Responsibilities:

  • Evaluate and improve contract manufacturers' processes through research, design, and collaboration.
  • Develop and optimize manufacturing processes and equipment in partnership with vendors.
  • Onboard and manage contract manufacturers, ensuring regulatory compliance.
  • Enhance manufacturing efficiency through workflow and layout analysis.
  • Design and implement testing methods to ensure product and process quality.
  • Serve as a key resource for manufacturing and quality-related inquiries.
  • Ensure compliance with regulatory standards to maintain product reputation.
  • Support design and development projects, including training contract manufacturers.
  • Maintain quality engineering functions such as supplier controls, audits, and validations.
  • Participate in Material Review Board and CAPA processes to address non-conformances.
  • Provide design control support for new product development, including risk management.
  • Drive continuous improvement of the Quality Management System (QMS).
  • Conduct internal and supplier quality audits.
  • Create and maintain documentation for product specifications, validations, and design history files.
  • Support QMS functions such as document control, training, and device history record management.

Requirements:

  • Bachelor's degree in engineering or a related technical field, or equivalent experience.
  • 6-8 years of experience in manufacturing and supplier quality engineering.
  • Experience with process validations and contract manufacturer management.
  • Background in medical devices and FDA-regulated industries.
  • Strong knowledge of ISO 13485 standards.
  • Excellent communication, organizational, and project management skills.
  • Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
  • Strong analytical and problem-solving abilities with a proactive mindset.

Additional Information



All your information will be kept confidential according to EEO guidelines.

Job Tags

Contract work, Immediate start,

Similar Jobs

Bath & Body Works

Retail Key Holder-PROMENADE AT TEMECULA MALL Job at Bath & Body Works

DescriptionCareer Development | Daily or Weekly Pay | Tuition-Free Benefits | Fun Stores | Free Product | 40% DiscountAt Bath & Body Works, everyone belongs. We are committed to creating a culture of belonging focused on delivering exceptional fragrances and experiences...

Good Samaritan Hospital

Clinical Data Abstractor Job at Good Samaritan Hospital

 ...thorough attention to detail and able to work with all levels of the department, keeping...  ...is a 286-bed hospital providing emergency, medical, surgical, obstetrical/gynecological and acute...  ...Bergen County, NJ. The hospital is home to a recognized cardiovascular program, comprehensive... 

Household Staffing

Nanny Job at Household Staffing

Private Family in Brooklyn, NY Seeking a Full-Time Live-Out NannyPosition: Full-Time Live-Out NannySchedule: MondayFriday, 7:00 AM...  ...a clean, organized, and calm environment~Occasionally travel with the family (optional, but a plus)Ideal Candidate & Personality... 

Diversified Transfer and Storage, Inc.

Class C Class A CDL Team Drivers Job Job at Diversified Transfer and Storage, Inc.

Class C Class A CDL Team Drivers JobAttention experienced team drivers! Join the exceptional team at Diversified Transfer & Storage (DTS) for a rewarding journey! Ready to hit the open road in a 2024 Volvo or Kenworth with your driving partner or partners? (And yes, pets... 

Domino's Franchise

Pizza Maker Starting Up to $12/Hr 2701 18th St Job at Domino's Franchise

 ...in our team members and our team members take pride in Domino's Pizza! Being the best pizza delivery company in the world requires exceptional...  ..., Representative, Services, Service Representative, Toppers, Pizza Hut, Amazon, Door Dash, Pappa Johns, Culvers, Chick-fil-A....