Product Release Specialist III

About the Company: Merz is a family-owned medical device and pharmaceutical company with headquarters in Germany. Our Global Technical Operations based in WI manufactures, packages, and ships several innovative products so that people all over the world can look better, feel better and live better.

Key Responsibilities:

Documentation Review:

• Ensure timely QA review of documentation to verify compliance to SOP’s and regulatory requirements.

 Final Release:

• Perform final review and release of finished Medical Device History Records.

Identifying Nonconformance:

• Identify and initiate NCA for nonconformance found during the final review of DHR’s.

Change Control:

• Maintain expertise in quality systems (e.g. assist and review SOP’s, initiate change control).

Training:

• Ensure training requirements are met and records are up to date.

Reporting:

• Maintain and update departmental metrics and required reports. 

Assist:

• Assist with continuous improvement initiatives / projects within the Manufacturing and Quality departments.

Certifications:

• Create and maintain the Product Conformance Certificates specific to Merz North America, Inc.

Represent:

• Work closely with the Packaging Department to provide on-going Quality support. Represent QA at cross-functional meetings, providing input and decision making.

Further Tasks:

• Assist with Incoming Inspections, returns and training duties.

Education: 

• High School diploma. Required

Experience: 

• Minimum of 2 year experience in the medical device field or other Quality Control/Quality Assurance trade. Required or Associate’s Degree with 1 year of experience.

Knowledge, Skills and Abilities: 

• Proficient in Microsoft Office applications (e.g. Word, Excel, Access, etc.). Required
• Demonstrate effectiveness in ability to train others, drive results, and meet deadlines. Required
• Familiarity with material, biocompatibility and microbiological test methods for evaluation of materials and finished medical devices. Required
• Communicate effectively and follow detailed written and verbal instructions. Required
• Cooperate with coworkers within an organized team environment. Required
• Knowledgeable in current GDP and GMP. Required
• Working knowledge of FDA regulations and other applicable regulations. Required
• Experience in Manufacturing operations.
• Detail oriented with a high quality of work. Required
• Strong customer focus. Required
• Ability to work with little or no supervision and make effective decisions. Required

Benefits:

• Comprehensive Medical, Dental, and Vision plans
• 20 days of Paid Time Off
• 15 paid holidays
• Paid Sick Leave
• Paid Parental Leave
• 401(k)
• Employee bonuses
• And more!

Your benefits and PTO start the date you're hired with no waiting period! Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!

 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Quality